Upstream/ Downstream Process Engineer (Automation)
Department: Commercial Drug Substance Manufacturing
Role Summary
We are looking for an Upstream/Downstream Engineer (Automation) to support GMP manufacturing while serving as an SME for automation systems (MES, DeltaV, Unicorn). You will partner with cross-functional teams to design, implement, and maintain automated manufacturing processes.
Key Responsibilities
- Act as Manufacturing SME for automation systems and process integration.
- Support facility design, system validation, and equipment integration (MES/PCS).
- Review and contribute to FAT/SAT, IQ/OQ, and related commissioning activities.
- Execute GMP upstream operations (cell culture, filtration, aseptic processing).
- Troubleshoot automation and process issues during routine manufacturing.
- Draft and review GMP documents (SOPs, MBRs, URS, etc.).
- Support investigations, deviations, and audit actions.
Requirements
- Degree in Engineering, Biochemistry, Automation, or related field.
- 2- 4 years of experience in automation within manufacturing or cleanroom environments preferred.
- Familiarity with MES, DeltaV, Unicorn systems.
- Knowledge of GMP, 21 CFR Part 11, EU Annex 11.
- Strong teamwork, communication, and problem-solving skills.
- Shift work is required
