Work Schedule
12 hr shift/days
Environmental 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.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll 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 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 and sterilization of materials.
- Responsible for packaging and transfer of the final product to Freezer.
- Always complete all the relevant training before performing any task.
- Responsible to perform all the materials and process (SAP) transactions at each manufacturing process steps.
- Strictly follow aseptic techniques and practices practice for aseptic operations.
- Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area.
- 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).
- Transfer materials for manufacturing a batch.
- 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.
- Perform stock check of consumables and inform Manager/Lead technician for required materials.
- Follow safety and quality compliance at all times and communicate in a timely manner to the Manager if any anomalies are observed.
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
- Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician.
- If required, perform Microbial sampling and swabbing of room and equipment.
- Liaison external vendors for instrument calibration and maintenance.
- If required and depending on product requirement, perform chemical and mathematical calculations to determine product potency and endotoxin levels for each batch formulation.
- 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.
Education
- Minimum “O” Level, NITEC/ITE education/Diploma in relevant field.
Experience
- 3 to 5 years of relevant experiences in pharmaceutical industry.
Knowledge, Skills, Abilities
- Good understanding of safe working practices and cGMP.
- Highly motivated to work in pharmaceutical Industry.
- Able to work rotating shift.