Sr Mfg Systems Engineer

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independentbiotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs,to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Sr Mfg Systems Engineer in Amgen Singapore Manufacturing.

Sr Mfg Systems Engineer

Live

What you will do

As a Sr Mfg Systems Engineer, you will be responsible to provide engineering domain expertise support to the manufacturing plants, utilities and site facilities operation to ensure consistent product supply and deliver production target. You will be entrusted with the responsibility to ensure maximum plant capabilities through continuous improvement initiatives and projects working with group of multi-functional experts. You are the hands-on leader actively involved in project delivery and provide the overall direction for the technical design, utilization and expansion of the automation control so that equipment and facilities will be optimized in accordance to Good Manufacturing Practice, Good Engineering Practice and in compliance with regulatory requirements as well as EHSS requirements.

Responsibilities

· Lead and run the development of new product launch, new capabilities and optimization operational project initiatives to facilitate technical transfer of new program into manufacturing and provide the automation solution

· Provides technical support for new equipment/process start-ups and operation

· Responsible for the execution of all design, build and run activities

· Ensure robust testing of new configuration features based on structure risk assessments

· Coordinate validation activities in collaboration with Manufacturing, IT, and QA

· Partner with multi-functional teams to ensure end-to-end process design and system integration to improve operational efficiency

· Find opportunities to improve existing control processes and equipment by demonstrating and setting industry best practices

· Lead complex operational plant solving efforts and investigation of production process, equipment, systems and code/configuration

· Perform Root Cause Analysis, develop corrective and preventive actions, effective countermeasures and implement the solutions to prevent recurrence

· Work closely with stakeholder to ensure production supply

· Collaborate with multi-functional team to resolve incidents, events or deviations

· Provide operational support to the GMP processes including some off-hours on-call support

· Support plant improvement initiatives and projects

· Active involvement in proposing the direction and implementation of the automation control

· Make changes to manufacturing process control under strict GMP change control management process to optimize processes and maintain compliance

· Update or develop standard operating procedures, work instructions, functional / design specifications associated with automation control and system

· Support engineering process performance management, audit and inspection

· Provide technical guidance to team of engineers

· Provide training to plant personnel on automation control process

· Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity

· Promote Safety, Quality and Compliance culture and continuous improvement mentality that lead to plant safety, quality and compliance to regulatory requirement

· Support Service Owner and System Owner roles for DeltaV, PLCs, and other site Automation systems at ASM

Win

What we expect of you

Qualifications

· Doctorate Degree in Engineering, Information Systems, Computer Science, or Life Sciences OR

· Master Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience OR

· Bachelor’s Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 4 years of directly related experience OR

· High School Diploma in Engineering, Information Systems, Computer Science, or Life Sciences / GED and 8 years of directly related experience

· Preferred 6+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries

· Hands on experience with automation systems and be particularly proficient in Emerson and Siemens technology

· Demonstrated ability to lead and run projects and work effectively as a teammate

· Solid understanding of pharmaceutical/biotech processes

· Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards

· Solid understanding of EHSS requirements

· Team player with excellent interpersonal and communication skills and ability to interact with a diverse group of people at multiple levels within the organization

· Able to work independently and get results on multiple assignments in fast-paced environment

· Excellent problem-solving skills and customer focused

· Proactive and willing to take on challenges

· Experience in supporting information interfaces, data conversion and network infrastructure

· Experience with installation, administration and solving computer data networks and servers is preferred

· Define, measure and improve system performance based on tangible metrics

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Snr/Occupational Health Nurse in Amgen Singapore Manufacturing.

Live

What you will do

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

As the Snr/Occupational Health Nurse you will be responsible to lead the Occupational Health (OH) Program for Amgen Singapore, which includes key aspects of both care management of employees and strategic OH planning.

As an integral part of EHSS team and being part of Amgen OH network, this role reports to EHSS Director and dotted line to Global OH Lead/designate. As Amgen Singapore adopts a Total Workplace Safety and Health approach, this role is essential in building a holistic and integrated approach to manage the interactions between work, safety and health to promote the well-being of both employees and Amgen Singapore.

Other scopes include injury/illness care, medical surveillance exams & testing, wellness screening, fitness center oversight, compliance tracking & record keeping, travel health consultation, emergency response and disaster preparedness.

Responsibilities:

• Manage OH programs for Amgen to optimize health care and return to work, assess health risks and ensure health-based programs are developed, documented, and implemented in accordance with both Singapore regulatory and Amgen’s requirements.
• Lead the operational activities for OH facilities – first aid room, nursing room and provide resources and physical health clearance to fitness facilities’ accesses.
• Render emergency medical care for employees, for example first aid treatment. Lead the First Aid Program for the site and ensure the readiness of first aiders in emergency response situations.
• Follow up with designated workplace doctor (DWD) on occupational related incidents and update the Amgen Incident Database. Instrumental in ensuring that work related incidents are properly managed, timely communicated and followed-up.
• Set up, manage and/or monitor medical/health contracts and service level agreements with external DWD, to ensure it is in line with company procurement standards, and continuously improve case management protocols.
• Manage site OH medical records in accordance to local regulatory requirements and Amgen record retention policy, including first aid records, equipment maintenance/ calibration records etc.
• Monitor and manage employees on routine medical surveillance program. Lead the site in pre-employment and regular medical assessment activities.
• Render OH SME support and advice in site’s Wellness program for Amgen Singapore in accordance to Amgen Corporate and Singapore HPB program. Partner with site Wellbeing Lead for a holistic Total Workplace Safety and Health solution in Amgen Singapore. Some examples include leading the general/targeted/interventional health screening or management, as well as healthy food programs.
• Oversee the site’s Return-to-Work program, as well as work accommodation plans.
• Partner closely with key stakeholders such as Human Resources department in the management of related OH programs for employees.
• Support employees with traveling health requirements (e.g. travel kits, vaccinations etc.) as part of Travel Health Program management.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Required Qualifications

• Bachelor’s degree in nursing or relevant qualification with practicing certificate and 4 years of directly related experience OR
• Diploma in nursing or relevant qualification with practicing certificate and 8 years of directly related experience
• Nursing Administration/ Management/ Advance Leadership Diploma is highly desirable

Preferred Qualifications

• Relevant industrial experience specifically in manufacturing industry, with minimum 3-5 years’ experience in Occupational Health.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

HOW MIGHT YOU DEFYIMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Business Analyst in Amgen Singapore Manufacturing.

Business Analyst

Live

What you will do

Amgen has established its presence in Singapore and has built a next generation biologics facility. We are seeking to appoint well-qualified and experienced individual to assume the role of Business Analyst. The Business Performance group at Amgen Singapore Manufacturing (ASM) is seeking candidates with a proven track record in application of Lean and Six Sigma methodologies, together with a proven record in the use of digital tools to increase productivity, maximizing efficiency, and managing human capital, equipment, and facilities more effectively.

The Business Analyst is responsible for identifying opportunities and remediating gaps between emerging business requirements / trends and current capabilities. The BA will utilize Operational Excellence (OE) and other digital / statistical tools and methodologies. The BA also supports the formulation of the site OE and Data strategies and drives its execution. The BA will also interface with internal and external OE and Lean networks / data scientists and industry groups.

Responsibilities:

· Identify opportunities to improve the manufacturing and business support processes to ensure the highest quality, lowest cost and shortest lead time.

· Utilize diverse tool set to provide key insights to business performance and communicate outcome to site stakeholder focusing on productivity initiatives.

· Participate in improvement efforts to close gaps leveraging robust improvement methodologies such as Lean and 6-Sigma.

· Support the implementation of Operations Operational Excellence programs e.g. Lean Transformation, Lean Business Systems, Human Performance, etc.

· Support site OE governance and develop / maintain tools for reporting of site metrics.

· Partner with business to Identify and implement productivity improvement projects

· Awareness of Lean / Six Sigmamethodologies.

· Coach and mentor staff working on yellow/green belt projects.

· Leverage current city planning tools such as (Tableau / Spotfire) to create striking visualizations to aid in data interpretation, presentation and usage

· Understanding business needs and co-create with cross functional team to develop novel yet practical data-driven solutions to meet those needs.

· Demonstrating knowledge in modelling and visualization approaches as part of proof-of-concept projects

· Exploring and evaluating new tools and techniques to improve the team’s operational capabilities.

· Helps foster a culture of continuous improvement through digital & data tools.

· Support training to site staff on various advanced data analytics platforms working with corporate partners

Win

What we expect of you Qualifications

· Doctorate degreeOR

· Master's Degree and 5 years of Engineering or Scientific experience OR

· Bachelor's Degree and 8 years of Engineering or Scientific experience OR

· Diploma and 10 years of directly related experience

· 5+ years of experience in Operational Excellence

· Certifications: Lean Six Sigma Black Belt

· Expert on Lean Manufacturing methodologies and in-depth knowledge of other Continuous Improvement methodologies along with practical experience with their application

· Experience with advanced statistical/analytical techniques and working knowledge of programming languages such as SQL, python.

· Proficiency in at least one statistical software package (such as SIMCA or JMP) Experience with data visualization tools or packages, such as Tableau and Spotfire

· Proven project management skills and demonstrated ability to execute and manage complex projects and programs.

· Strong analytical and creative thinking skills for effective decision-making

· Strong communication, presentation, and executive presence skills

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

· Vast opportunities to learn and move up and across our globalorganization

· Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

· Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Data Scientist in Amgen Singapore Manufacturing.

Data Scientist

Live

What you will do

As part of its global expansion strategy, Amgen has built a next generation biologics facility in Singapore and we are seeking to appoint well-qualified and experienced individual to assume the role of Data Scientist. This role reports into Digital Technology and Innovation (DTI). DTI function at Amgen Singapore Manufacturing (ASM) is responsible to deliver and maintain reliable, resilient, and secure digital, data, and technical capabilities. We are seeking candidates with a proven track record in data visualization, engineering & modelling to develop AI models, statistical and predictive models to uncover data insights to optimize efficiency and productivity for the site manufacturing operations.

The Data Scientist will provide end to end accountability of site Data governance & visualization strategies. The DS will support the data visualization requirement from the business and continually remediate, streamline current data and reporting gaps. The DS would partner with global DTI, Data teams and industry partners to explore and drive the adoption of emerging technologies in AI and Machine Learning.

Responsibilities:

• Collaborate with cross functional teams incl OE & network to analyze and co-create data models & algorithms that focus on gaining data insights to improve business process or value

• Design, write, and test data / ML pipelines / LLM and other advanced analytic / visualization or AI solutions.

• Prioritize & lead the implementation of internally developed and externally provided analytic solutions.

• Coordinate & project manage the delivery / development of data / ML pipelines / LLM and other advanced analytic / visualization or AI solutions.

• Collect business requirements / user stories for new or enhancements to existing analytic solutions.

Internal Use Only General and Administrative

• Translate business requirement / pain point to Machine Learning use case to resolve real world business problems

• Implement most recent algorithms and approaches for machine learning

• Initiates and participates in projects in prediction, optimization, and processes using advanced Deep Learning / Statistical / Mathematical approach

• Provide technical oversight and guidance to other Data Analytics team members

Win

What we expect of you

Qualifications

Basic Qualifications

• Doctorate degree in Computer Science, Software Engineering, Data Science, Statistics or Similar field OR

• Master’s degree in Computer Science, Software Engineering, Data Science, Statistics or Similar field and 2 years of directly related experience OR

• Bachelor’s degree in Computer Science, Software Engineering, Data Science, Statistics or Similar field and 4 years of directly related experience OR

• Diploma and 8 years of directly related experience

• Certifications: Data Scientist, AI and Machine Learning

• Experience working in a regulated or GxP environment

• Experience with scripting and programming languages such as SQL,Python, Java, C++

• Experience with MLOps, NLP, Snowflake, deep learning frameworks like TensorFlow

• Experience developing or deploying Gen AI, LLM models like OpenAI, Vertex AI and Gemini

• Experience developing data visualization tools such as Tableau and Data Intelligence platform like Databricks

• Proven project management skills and demonstrated ability to execute and manage complex projects and programs

• Strong analytical and creative thinking skills for effective decision-making

• Strong communication, presentation, and executive presence skills

• A demonstrable ability to work in teams and serve as a technical mentor to junior team members

• Agility and flexibility to adapt to changing priorities.

• Experience working effectively in a globally dispersed team environment.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Internal Use Only General and Administrative

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

API Associate Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an API Associate Manufacturing in Amgen Singapore Manufacturing.

API Associate Manufacturing

Live

What you will do

The associate manufacturing will be required to work on a rotational overnight shift to support daily production requirements. Operations, maintenance and analytical testing will be performed as required according to Standard Operating Procedures (SOPs) and Job Plans. The associate manufacturing will perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and assist in technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The associate manufacturing may participate on cross-functional teams, and may identify, recommend and implement improvements related to routine functions.

Responsibilities:

• Responsible for manufacturing synthetic API’s and executing manufacturing duties
• Support daily production requirements throughout the facility
• Ensure that operations, maintenance and analytical testing be performed according to Standard Operating Procedures (SOPs) and Job Plans
• Perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records and SOPs
• Perform basic troubleshooting
• Assist in the review of documentation for assigned functions
• Responsible for identifying, recommending and implementing improvements related to routine functions
• Ensure that operations are conducted in a safe and compliant manner

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Qualifications

• Bachelor’s Degree in Science or Engineering and 2 years of directly related experience OR
• Associate’s Degree in Science or Engineering and 4 years of directly related experience OR
• High School Diploma in Science or Engineering / GED and 6 years of directly related experience
• Possess minimum 0 - 2 years of relevant experience in the pharmaceutical or petrochemical industry. Fresh graduates will be considered.
• Experience and basic troubleshooting skills with process equipment
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Ability to adhere to written procedures and safety guidelines
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Ability to organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Problem solving skills
• Proficient presentation and facilitation skills
• Mechanical ability/expertise
• Understanding of analytical methods
• Ability and willingness to work any shift in support of operations that may include 24/7 in a team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Associate Manufacturing I in Amgen Singapore Manufacturing.

Associate Manufacturing

Live

What you will do

• Perform solution and equipment preparation, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.
• Involve in hands-on execution of the plant operations and assist Manufacturing Associates in troubleshooting.
• Monitor and analyze processing parameters for atypical trends and improvement opportunities.
• Perform solution and equipment preparation.
• Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility.
• Stage components for autoclaving and washing.
• Perform filter integrity testing of sterilizing filters.
• Perform environmental monitoring of classified manufacturing cleanroom
• Support in-process testing of production samples, prior experience with analytical instrument will be a plus point.
• Actively support continuous improvement initiatives
• Support Safety audits
• Adhere to any applicable EHS requirements
• Regulatory knowledge
• Understanding of analytical methods
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Qualifications

• Bachelor’s degree and 2 years of directly related experience OR
• Associate’s degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Basic statistical mathematical skills
• Ability to organize work and handle multiple priorities and meet deadlines
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Career Category

Job Description

Associate Manufacturing I

Amgen Singapore Manufacturing, Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Associate Manufacturing I in Amgen Singapore Manufacturing.

Associate Manufacturing

Live

What you will do

• Perform solution and equipment preparation, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.
• Involve in hands-on execution of the plant operations and assist Manufacturing Associates in troubleshooting.
• Monitor and analyze processing parameters for atypical trends and improvement opportunities.
• Perform solution and equipment preparation.
• Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility.
• Stage components for autoclaving and washing.
• Perform filter integrity testing of sterilizing filters.
• Perform environmental monitoring of classified manufacturing cleanroom
• Support in-process testing of production samples, prior experience with analytical instrument will be a plus point.
• Actively support continuous improvement initiatives
• Support Safety audits
• Adhere to any applicable EHS requirements
• Regulatory knowledge
• Understanding of analytical methods
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Qualifications

• Bachelor’s degree and 2 years of directly related experience OR
• Associate’s degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Basic statistical mathematical skills
• Ability to organize work and handle multiple priorities and meet deadlines
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Career Category

Job Description

API Associate Manufacturing

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an API Associate Manufacturing in Amgen Singapore Manufacturing.

API Associate Manufacturing

Live

What you will do

The associate manufacturing will be required to work on a rotational overnight shift to support daily production requirements. Operations, maintenance and analytical testing will be performed as required according to Standard Operating Procedures (SOPs) and Job Plans. The associate manufacturing will perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and assist in technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The associate manufacturing may participate on cross-functional teams, and may identify, recommend and implement improvements related to routine functions.

Responsibilities:

• Responsible for manufacturing synthetic API’s and executing manufacturing duties
• Support daily production requirements throughout the facility
• Ensure that operations, maintenance and analytical testing be performed according to Standard Operating Procedures (SOPs) and Job Plans
• Perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records and SOPs
• Perform basic troubleshooting
• Assist in the review of documentation for assigned functions
• Responsible for identifying, recommending and implementing improvements related to routine functions
• Ensure that operations are conducted in a safe and compliant manner

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Qualifications

• Bachelor’s Degree in Science or Engineering and 2 years of directly related experience OR
• Associate’s Degree in Science or Engineering and 4 years of directly related experience OR
• High School Diploma in Science or Engineering / GED and 6 years of directly related experience
• Possess minimum 0 - 2 years of relevant experience in the pharmaceutical or petrochemical industry. Fresh graduates will be considered.
• Experience and basic troubleshooting skills with process equipment
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Ability to adhere to written procedures and safety guidelines
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Ability to organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Problem solving skills
• Proficient presentation and facilitation skills
• Mechanical ability/expertise
• Understanding of analytical methods
• Ability and willingness to work any shift in support of operations that may include 24/7 in a team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Career Category

Job Description

Specialist Manufacturing (Process Support)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Specialist Manufacturing in Amgen Singapore Manufacturing.

Specialist Manufacturing (Process Support)

Live

What you will do

The Specialist Manufacturing will be reporting to the Senior Manager Manufacturing, we are seeking to appoint a well-qualified and experienced individual to assume the role of Manufacturing Specialist. With minimal direction or supervision, the Manufacturing Specialist has three main core responsibilities: Contamination control, Inspection readiness and Productivity. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network.

Main Responsibilities:

Contamination Control

• Contamination Control Lead for ASM1 Manufacturing

  • Lead contamination program and strategies in ASM1 manufacturing.

  • Represent ASM1 Manufacturing in the Contamination Control Network (CCN) and actively collaborate with the network

  • Responsible for metrics review and reporting pertaining to the contamination control program

  • Serve as subject matter expert during regulatory inspections for contamination control related topics

• Maintain clean room procedures, gowning practices, contamination response and oversee the environmental monitoring program.

• Perform routine monitoring, identify weak signals and provide prompt follow ups to mitigate potential contamination risks.

• Ensure adherence and alignment to regulatory guidelines and standards, and network requirements.

• Lead and drive root cause analysis investigations arising from contamination events/deviations including the development and implementation of corrective and preventive actions with minimal supervision

• Identify and drive opportunities to optimize ASM1 Manufacturing’s contamination control program and its effectiveness

• Support gowning training where applicable as qualified trainer.

Inspection Readiness

• Serve as Pre-Approval Inspection (PAI) Lead for ASM1 Manufacturing

  • Work closely with Compliance and cross-functional teams to ensure prompt follow-ups on inspection requests

  • Develop and build up ASM1 Manufacturing’s technical expertise and capabilities to ensure site inspection readiness (e.g., pressure tests)

• Triage lead for ASM1 Manufacturing during regulatory inspections / audits

• Establish defined timelines and provide follow ups on audit findings, near misses and lessons learnt

• Working knowledge of key systems including change controls, deviations / investigations, corrective / preventive actions

• Support ASM2 Manufacturing to ensure ASM2 Manufacturing inspection readiness (areas related to change controls and deviations)

Process Support

• Spearhead and champion ASM1 Manufacturing Productivity Ideation to cultivate continuous improvement culture and build a robust productivity initiatives pipeline – to drive productivity savings

  • Use of Operational Excellence (OE) tools (e.g., value stream mapping, elimination of waste) to advance productivity initiatives (from ideation to realisation)

• Identify and implement continuous improvement initiative to enhance operational stability.

• Responsible for the maintenance and continuous refresh of ASM1 Manufacturing Support Team (MST) dashboard

  • To advance and optimize the MST dashboard to incorporate meaningful performance metrics

• Trained SME on Failure Mode and Effective Analysis (FMEA) and maintain risk assessments pertaining to ASM Manufacturing

  • Serve as facilitator in FMEA risk assessment discussions and engage key stakeholders appropriately to manage risk assessment revisions / updates ensuring continued compliance

• Lead, manage and implement change controls independently where applicable.

Win

What we expect of you

Qualifications

• Doctorate degree OR

• Master’s degree and 2 years of related experience OR

• Bachelor’s degree and 4 years of related experience OR

• Diploma and 8 years of directly related experience

• Technical knowledge of biopharmaceutical upstream, downstream processing and single use system

• Understanding of regulatory guidelines and requirements pertaining to contamination control in biologics manufacturing

• Strong communication skills – ability to to communicate effectively with the cross-functional stakeholders and network partners 

• Ability to work under minimal guidance and drive continuous improvement initiatives and lead highly complex investigations

• Strong analytical and critical thinking capability – ability to respond to changes, gather required data, evaluate options, and communicate analysis recommendations to facilitate decision making

• Ability to coach, train and develop Manufacturing Associates

Your selection for this role w be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.