Workplace : Tuas Biomedical Park with company transport provided islandwide
Responsibilities
- Lead Change Requests (CR) for the Drug Substance upstream (USP) process function. Changes may arise from CAPA, policy updates, technology transfers, lean initiatives, safety implementations, audits, and other sources.
- Collaborate cross-functionally with Process Development, Project Management, Validation, and MSAT teams on technology transfer and process validation to achieve organizational goals.
- Work closely with QA/QC teams on the creation and revision of relevant quality documents.
- Lead manufacturing activities and coordinate production for assigned projects within the USP function.
- Draft, amend, and review GMP documentation, including but not limited to SOPs, MBRs, and PRTs.
- Review GMP documents within the MC system to ensure compliance with formatting standards and SOP requirements.
- Participate in investigations and implementation of changes and deviations, including executing audit corrective action plans.
- Manage daily administrative activities within the department.
- Perform any other duties as assigned by the direct supervisor.
Requirements
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, General Engineering, Biochemistry, Electrical, or Instrumentation disciplines.
- 2 - 5 years of experience in managing USP-related projects or Change Requests (CR) in a similar manufacturing or cleanroom environment.
- Knowledge of MES and PCS systems (e.g., DeltaV, Unicorn) in production environments is preferred.
- Strong coordination and interpersonal skills, with the ability to work across departments and disciplines to drive project success.
- Good understanding of GMP, 21 CFR Part 11, and EU Annex 11 regulations and requirements.
- Positive, team-oriented mindset.
- Self-motivated, adaptable, and able to work in a fast-paced environment to meet aggressive timelines.
