Job Description

Work Schedule Flex 12 hr shift/nightsEnvironmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materialsWhen you\xe2\x80\x99re part of the team at Thermo Fisher Scientific, you\xe2\x80\x99ll do important work. Surrounded by collaborative colleagues, you\xe2\x80\x99ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make meaningful contributions to the world.The incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and the safety regulations.ResponsibilitiesSetup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, autoclave, parts and vial washers, depyrogenation tunnel, formulation process, HMI and automatic CIP/SIP processes as well as inspection and packaging line equipment (e.g. AVIM, labelling and carton machine etc.) as per relevant SOPs and the Batch Record.Responsible for formulation activities of production batches which includes formulation and/or dispensing of all the available drug substance(s) and excipients.Responsible for parts preparation, washing, sterilization of materials and production equipment.Responsible for packaging and transfer of the final product to Freezer.Strictly follow aseptic techniques and practices practice for aseptic operations.Perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g. bioburden sampling, waler sampling) and chemical and physical tests during the processing of the batch (e.g. pH testing), if applicable.Timely completion of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice).Prepare filters for test execution and perform FIT (filter Integrity testing).Perform visual inspection, labeling and packaging on finished drug products. Perform in-process sampling on semi-finished drug products. Conduct in-process inspection and checks.Any other duties as and when assigned by the Manager.EducationMinimum Diploma in relevant field.Experience3 to 5 years of relevant experiences in pharmaceutical industry.Knowledge, Skills, AbilitiesGood understanding of safe working practices and cGMP.Highly motivated to work in pharmaceutical Industry.Able to work as a team.Able to work rotating shift.Sterile filling experience.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific