Lead Process Engineer / Senior Process Engineer

We are seeking a Process Engineer / Senior Process Engineer to support commissioning and qualification of biopharma process equipment and systems.
The role involves hands-on CQV execution for upstream and downstream process equipment, ensuring alignment between equipment functionality, control logic, and process recipes. The engineer will also support technical transfer activities, process studies, and PQ readiness, ensuring compliance with GMP and regulatory standards.

Key Responsibilities

• Lead or support CQ and IQ/OQ execution for process equipment and associated systems (bioreactors, skids, chromatography, filtration, CIP/SIP, and buffer prep).

• Develop, review, and execute CQV deliverables URS, DQ, FAT/SAT, IQ, OQ, PQ protocols, and reports.

• Ensure documentation and test results meet GxP and data-integrity requirements (ALCOA+).

• Coordinate with automation, mechanical, and QA teams for issue resolution and deviation closure.

• Provide end-to-end process understanding flow, control logic, equipment interlocks, and sequence.

• Review and validate process recipes and control strategies in alignment with manufacturing requirements.

• Support process simulation and recipe testing during commissioning and qualification phases.

• Collaborate with automation and MES teams to ensure process alignment with Batch Logic / ISA-88.

• Participate in Process Studies, NPI, and PQ execution phases post OQ readiness.

• Support tech transfer between manufacturing suites or sites (process/equipment fit gap).

• Collaborate with process development and operations teams for parameter alignment and run readiness.

• Ensure smooth handover to manufacturing with validated, robust, and compliant systems.

• Ensure CQV deliverables meet site and global quality standards.

• Participate in audits, walkthroughs, and readiness reviews.

• Drive continuous improvement in qualification methodology, data management, and test efficiency.

• Degree: Bachelors or Masters in Chemical / Bioprocess / Mechanical / Instrumentation Engineering.

• Experience:

  • 8+ years in biopharma process engineering / CQV.

  • Hands-on experience in qualification of process equipment (bioreactors, CIP/SIP, skids, chromatography).

  • Strong understanding of process control logic, instrumentation, and automation interfaces (DeltaV / PLC).

  • Knowledge of process flow, utilities, clean-in-place, and sterilization cycles.

  • Familiarity with PQ, process validation, and data trending.

• Knowledge: GxP, GAMP5, ISPE Baseline Guides, 21 CFR Part 11, Annex 15.