This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Work Schedule
Flex 12 hr shift/days
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Job Description
- Please note this is a 12-hours rotating shift role*
Position Summary
The incumbent will support site wide routine operation and preventive maintenance, ad-hoc corrective maintenance to process equipment, utilities and facilities system. The incumbent may also be required to support equipment / instrument calibration and performance. Aligning with cGMP, EHS, Data Integrity, and regulatory requirements is a must for all tasks.
Responsibilities
- Sterile manufacturing equipment maintenance such as filling, autoclave and part washer.
- Participate in problem solving discussions with multi-functional team to identify/define root cause, evaluate alternative solutions, and develop action plans.
- Execute the routine maintenance for the production equipment, control systems, automated filling lines, packaging etc in a timely manner and in compliance with Engineering standards and safety procedures.
- Complete training provided timely to improve proficiencies.
- Contribute to team effort by achieving desired results/important metrics. Share Knowledge and mentor colleagues to build up their proficiencies and provide training.
- Manage third-party vendor who is contracted to perform routine preventive maintenance, corrective maintenance and any other maintenance related activity.
- Ensure all GMP documentation related to maintenance activities is completed accurately and processed to full completion in compliance to data integrity requirement.
- Carry out any other duties and responsibilities as assigned by supervisor, including but not limited to the above.
Minimum Requirements/Qualifications
- NITEC or Diploma in Engineering related qualifications
- Minimum 8 years with experience in the pharmaceutical industry, biopharma, and medical devices.
- Strong understanding of facilities and utilities systems and process equipment related validation / GMP requirements.
- Strong electrical knowledge is essential
- Safety certificates, example, confined space, will be advantage.
Competencies
- Able to work in a fast pace and a regulated environment.
- Able to plan, schedule, organize, prioritize day to day activity.
- Having a strong knowledge of various RCA tools and skills.
- Able to work independently.
- Able to work rotating shift.
