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 qualificationsMinimum 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 essentialSafety 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.