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Rotational shift nights/weekendsEnvironmental 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 -22degreesF/-6degrees C Loud Noises (Equipment/Machinery) No contact lens 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.) Warehouse Will work with hazardous/toxic materialsJob Description
When youre part of the team at Thermo Fisher Scientific youll do important work. Surrounded by collaborative colleagues youll 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.
Responsibilities
Setup 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 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 and sterilization of materials packaging and transfer of the final product to Freezer.
Closely follow aseptic techniques and practices for aseptic operations.
Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area.
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).
Provide for the loading/unloading of the loads/batch from the equipment during production activities.Transfer materials for manufacturing a batch.
Perform stock check of consumables and inform Manager/Lead technician for required materials.
Follow safety and quality compliance .
Participate in EHS Business Compliance cGMP and all other compliance-related matters.
Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP.
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.
Requirements
Minimum O Level NITEC/ITE education/Diploma in relevant field.
3 to 5 years of experience in the pharmaceutical industry.
Good understanding of safe working practices and cGMP.
Highly motivated to work in the pharmaceutical industry.
Strong great teammate.
Ability to work rotating shifts.
Required Experience:
IC
Full-Time