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

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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.

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

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.