Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)
Responsibilities
- Oversee instrument readiness, cell expansion, cell culture operations, depth filtration, and other process activities in accordance with GMP requirements. Perform aseptic procedures such as vial thawing.
- Supervise environmental monitoring (EM) during recovery activities as authorized by QC.
- Ensure proper cleaning of cleanroom areas in line with GMP standards, including periodic cleaning, changeover cleaning, and equipment cleaning.
- Lead the drafting, revision, and maintenance of SOPs, MBRs, URS, FAT/SAT documentation, and other controlled documents.
- Oversee and participate in investigations, change control, deviation management, and audit/inspection follow-up actions.
- Escalate issues related to process performance, personnel, safety, production environment, and equipment maintenance to leadership promptly.
- Oversee staff training or coordinate required training activities, ensuring timely completion and accurate maintenance of training records.
- Communicate with Engineering and other relevant departments to coordinate equipment maintenance, calibration, and facility support needs.
- Support GMP activities within the department, including logbook review, BPR review, cleaning and sterilization of parts and consumables, and other assigned duties.
- Lead or contribute to drafting and updating SOPs, MBRs, and related documentation.
- Provide oversight for daily upstream operations.
- Oversee cell bank management activities.
- Participate in and support technology transfer projects.
- Oversee sample handling and sample management tasks.
- Support team development through staff capability building, succession planning, and fostering a positive team environment.
- Oversee equipment management and maintenance processes.
- Manage routine administrative tasks for the team and support departmental administrative needs.
- Perform any other responsibilities assigned by the direct Supervisor.
Requirement :
- Diploma / Bachelor's degree in Chemical Engineering, Biochemical Engineering, General Engineering, Biochemistry, Electrical & Instrumentation, or a related discipline.
- 8 - 10 years of relevant experience in a manufacturing or cleanroom environment is advantageous.
- People management experience is required
- Familiarity with production automation and control systems such as MES, PCS (e.g., DeltaV, Unicorn) is an advantage.
- Strong coordination and interpersonal skills with the ability to collaborate across functions and disciplines.
- Good understanding of GMP principles and familiarity with regulatory requirements such as 21 CFR Part 11 and EU Annex 11.
- Teamoriented mindset with a positive, collaborative attitude.
- Selfdriven, adaptable, and able to work effectively in a fastpaced environment.
