- Execute manufacturing operations in accordance with cGMP, site procedures, and safety requirements.
- Perform equipment cleaning, preparation, setup, and operational activities.
- Upstream processing (Vial Thaw, Inoculation, Cell Culture and Recovery)
Key Responsibilities
Manufacturing Operations
- Execute manufacturing operations in accordance with cGMP, site procedures, and safety requirements.
- Perform equipment cleaning, preparation, setup, and operational activities.
- Support biologics manufacturing processes including:
- Upstream processing (Vial Thaw, Inoculation, Cell Culture and Recovery)
- Downstream processing (Chromatography, Filtration, Ultrafiltration, Final Filling)
- Central Services activities (Buffer/Media Preparation, Autoclave, Glasswash Operations, Cleaning Activities, and Raw Material Sampling)
- Perform daily tasks assigned by the Lead Biotechnologist or Manufacturing Supervisor.
Documentation & Compliance
- Complete batch records and manufacturing documentation accurately, legibly, and in a timely manner.
- Review documentation to ensure completeness and accuracy.
- Support timely resolution of documentation discrepancies and batch record errors.
- Maintain compliance with regulatory, quality, and cGMP requirements.
Production Support & Troubleshooting
- Support production schedules and manufacturing plans.
- Assist in troubleshooting manufacturing issues during shift operations.
- Escalate process deviations, equipment issues, and unplanned downtime to supervisors promptly.
- Maintain appropriate inventory levels to support continuous operations.
- Ensure all required training is completed and remains current.
Safety & Quality
- Adhere to all Environmental, Health and Safety (EHS) policies and standards.
- Support audit and inspection readiness activities.
- Contribute to maintaining overall plant housekeeping and operational readiness during assigned shifts.
Requirements
Education
- NITEC, Diploma, or equivalent qualification in Biotechnology, Life Sciences, Engineering, Chemical Engineering, or a related discipline.
Experience
- Minimum 2 years of relevant experience in biotechnology, pharmaceutical, biologics, or GMP manufacturing environments.
- Experience in biologics manufacturing operations is advantageous.
- Experience working in regulated manufacturing environments is preferred.
Technical Knowledge
- Understanding of cGMP manufacturing requirements and quality systems.
- Familiarity with manufacturing systems such as SAP, LIMS, and MES is advantageous.
- Knowledge of upstream or downstream biologics manufacturing processes is beneficial.
Soft Skills
- Strong attention to detail and documentation accuracy.
- Good problem-solving and troubleshooting skills.
- Able to work independently and collaboratively within a team environment.
- Good communication and interpersonal skills.
Preferred Skills
- Biologics manufacturing experience
- GMP documentation and batch record management
- Process troubleshooting
- SAP, LIMS and MES systems
- Continuous improvement mindset
- Shift operations experience
We regret to inform that only shortlisted candidates will be notified.
Job Reference: R25150511 Cammy Li Xin Hui
Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544
