Lead Process Engineer / Senior Process Engineer

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading company in biopharma engineering is seeking a Process Engineer/Senior Process Engineer located in Singapore. The role involves hands-on execution for commissioning and qualification of equipment, ensuring compliance with GMP and regulatory standards. The ideal candidate has over 8 years of experience in biopharma engineering and strong knowledge of process control. Competitive salary and benefits package offered.

Qualifications

• 8+ years in biopharma process engineering/CQV.
• Hands-on experience in qualification of process equipment.
• Strong understanding of process control logic and automation.

Responsibilities

• Lead CQ and IQ/OQ execution for process equipment.
• Ensure documentation meets GxP and data-integrity requirements.
• Collaborate with teams for process alignment and issue resolution.

Skills

CQV execution

Process engineering

Process control logic

Automation interfaces (DeltaV / PLC)

Education

Bachelors or Masters in Chemical/Bioprocess/Mechanical/Instrumentation Engineering

Tools

Bioreactors

CIP/SIP systems

Chromatography

Job description

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

CQV Execution & Oversight

• 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.

Process & Technical Responsibilities

• 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.

Technical Transfer & Operations Support

• 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.

Compliance & Continuous Improvement

• 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.

Qualifications & Experience

• 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.