Work Schedule
12 hr shift/nights
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), 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 materials
Job Description
What will you do?
Thermo Fisher Scientific in Singapore is seeking a Lead Manufacturing Technician who will be instrumental in our mission to improve global health, cleanliness, and safety. In this role, you will manage a team to successfully meet production targets and schedules, ensuring compliance with world-class standards of cGMP, safety, and housekeeping. Your ability to closely monitor production activities, allocate personnel and equipment efficiently, and drive continuous improvement will be vital.
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Responsibilities
- Monitor production activities to ensure processes align with SOPs and process descriptions, completing batch documentation closely adhering to quality and safety standards.
- Assist the Production Leader with day-to-day production activities, approving required production cycles.
- Ensure efficient allocation of personnel and equipment, liaising with associated departments for day-to-day issues.
- Report and assist in investigating quality deviations, troubleshooting and resolving problems during processing.
- Ensure the correctness and timely submission of completed batch sheets.
- Adhere to cGMP and GDP practices, approving and closing out safety work permits.
- Attend and contribute to team meetings and other required meetings.
- Coordinate preventive and breakdown maintenance, ensuring Operations coordination of CM/PM/Calibration activities in the production area.
- Lead Continuous Improvement activities as assigned to improve Quality and Efficiency.
- Operate pharmaceutical production equipment, including high-speed filling lines, Lyophilizers, Autoclaves, and automatic packaging line equipment, following SOPs and Batch Records.
- Perform formulation activities of production batches, including dispensing drug substances and excipients.
- Complete all relevant training before driving any task, every time.
- Perform materials and process transactions at each manufacturing step per SOPs and Batch Records.
- Adhere strictly to aseptic techniques for aseptic operations.
- Conduct cleaning and upkeep of production equipment and classified areas per SOPs and Batch Records.
- Carry out routine QC sampling and in-process testing, including bioburden and water sampling, and prepare filters for FIT.
- Follow safety and quality compliance, reporting anomalies promptly.
- Participate in EHS, Business Compliance, and cGMP matters.
- Perform all tasks per SOPs, maintaining strict GMP compliance, and reporting quality issues immediately.
- Perform chemical and mathematical calculations for product potency and endotoxin levels as required.
- Undertake any other duties as assigned by the Manager.
How will you get here?
Education
- Minimum "O" Level, NITEC/ITE education or Diploma in a relevant field.
Experience
- Minimum 5 years of relevant experience in the pharmaceutical industry.
Knowledge, Skills, Abilities
- Good understanding of safe working practices and cGMP.
- Highly motivated to work in the pharmaceutical industry.
- Able to work as a team.
- Able to work rotating shifts.