Total 3 job vacancies by Thermo Fisher Biopharma Services Pte. Ltd.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Job position summary

The incumbent will be taking accountability for maintenance activities (planned and unplanned), utilising operational excellence and continuous improvement activities to improve equipment reliability and ensure minimal equipment downtime. During maintenance incidents, the incumbent will actively use problem solving and lean manufacturing techniques to identify the true root cause of the issue – and implement corrective actions.

Responsibilities

• Responsible for the operation and maintenance of sterile manufacturing process equipment but not limiting to formulation and fill machines.
• Draft validation protocol and complete the validation task in accordance with standard operation procedure (SOP) steps.
• Draft and prepare maintenance SOP and PM plan.
• Lead process equipment changes by working with a multi-functional team. This includes equipment improvement and format change parts request.
• Take up the role of deviation lead investigator and work with a multi-functional team.
• Support internal and regulatory audit. Be the manager fronting the regulatory auditor.
• Complete all routine maintenance, periodic review, routine qualification on time and in compliance with engineering standard, GDP requirement and safety.
• Carry out any other duties and responsibilities as assigned by the manager.
• Be familiar with change control and quality ownership.
• Utilise external resource, where appropriate, to acquire services/components, generating, completing and acquiring the appropriate documentation and approval to proceed (e.g. Purchase Orders, spares requests, quotations, etc.)
• Supervise and control spares in an efficient manner

Education

University degree in engineering

Experience

Proven experience in maintenance of sterile fill finish process equipment and its related validation.

SAP/CMMS knowledge is an advantage.

Proficiencies

Able to work in a fast pace and a regulated environment.

Able to plan, schedule, organise, prioritise and coordinate the work assigned.

Good understanding of production process and related validation/GMP requirements

Good equipment troubleshooting skill and a good knowledge of RCA tools.

Able to work independently and to hands on to perform machine maintenance work.

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Discover Impactful Work:

Responsible to maintain the equipment and utilities in the same state as it was qualified. Collaborate with a multi-functional team to meet production and quality goals.

A day in the Life:

• Review equipment system design, Factory Acceptance Test (FAT), installation/ Site Acceptance Test (SAT) commissioning/ validation.
• Coordinate maintenance activities, includes prevention maintenance, corrective maintenance and spare part management.
• Supplier management, external maintenance third party vendor management.
• Create and update SOP/WI and other operation documentation. Ensure department GMP procedures are in compliance with relevant company policies and regulatory requirements.
• Facilitate execution of quality deviation, change control and corrective and preventive action (CAPA) etc.
• Act as clean utilities and HVAC SME in regulatory audit or customer audit.
• Own the maintenance related OPEX budget, lead and implement the site driven projects, handling subcontractors for successful execution
• Implementing site wide EHS procedures for maintenance activities and actively drive safety & quality culture.
• Education
  
• · Bachelor of Engineering with shown ability.
  
• Experience
  
• Good knowledge in GMP, clean utilities, HVAC and Data integrity in a sterile manufacturing environment.
• Knowledge, Skills, Abilities
  
• Shown knowledge on equipment maintenance, preventive maintenance and spare part management.
• Experience on equipment package CQV (commissioning, qualification and validation) is helpful.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and outstanding contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Singapore/PSG

Reporting to the QC Manager Chemistry, the role is responsible for writing laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role gives to building and maintaining QC lab cGMP system, delivers analytical solution to clients through expertise in specific method qualification and validation strategies while ensuring timely delivery for projects. The role will be driving activities such as testing for incoming materials, in-process products and DS testing, etc.

Responsibilities:

• To support new equipment qualification, lab computerized system and new chemistry lab set up
• To perform transfer/verification/validation of laboratory procedures within the team where required
• To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations and reports.
• Lead lab system deployment and routine maintenance as site SME, e.g., CDS, LIMS.
• To perform analysis of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.
• To review analytical and laboratory data within the department for accuracy, completeness and compliance with detailed procedures.
• To perform planned preventative maintenance and performance calibrations on equipment.
• Management of QC chemical, reference standard and consumable stock levels
• To maintain own training records and support and train other team members as required.
• To communicate effectively on site and internationally, and to participate with them in problem solving activities.
• Participate/chip in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
• Support and encourage a “Quality Culture” and company 4i values throughout QC
• Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.
• To work with HSE, cGMP and 5S in mind at all times.
• Undertake ad-hoc activities that may be required by the business
• ·To support shift work (if necessary) in future

Keys to Success:

Education

• Degree in Chemistry or strongly related scientific field

Experience

• At least 5 years relevant industrial experience
• Experience in equipment such as Capillary Electrophoresis (CE), Microplate Reader preferred
• Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Ability to work independently and adhere to critical timelines
• Effective communication skills at all internal and external levels
• Excellent attention to detail
• Excellent organisational skills