Automation Engineer, Upstream/Downstream Process

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