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 -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materials
Job Description
Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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The incumbent will perform various tasks and activities listed below for which they are appropriately trained and in compliance with the cGMP, company and department SOPs and the safety regulations.
Key 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.
- Responsible for 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).
- Perform stock check of consumables and inform Manager/Lead technician for required materials.
- Follow safety and quality compliance and communicate 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.
- Perform in-process sampling on semi-finished drug products.
- Any other duties as and when assigned by the Manager.
Education
- Minimum "O" Level, NITEC/ITE education/Diploma in relevant field.
Experience, Knowledge, Skills, Abilities
- 1 to 5 years of work experiences in pharmaceutical industry or any industry.
- Good understanding of safe working practices and cGMP.
- Highly motivated and able to work as a team.
- Able to perform rotating shift.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.