Lead Process Engineer Senior Process Engineer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
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Lead or support CQ and IQ/OQ execution for process equipment and associated systems (bioreactors skids chromatography filtration CIP/SIP and buffer prep).
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Develop review and execute CQV deliverables URS DQ FAT/SAT IQ OQ PQ protocols and reports.
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Ensure documentation and test results meet GxP and data-integrity requirements (ALCOA).
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Coordinate with automation mechanical and QA teams for issue resolution and deviation closure.
Process & Technical Responsibilities
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Provide end-to-end process understanding flow control logic equipment interlocks and sequence.
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Review and validate process recipes and control strategies in alignment with manufacturing requirements.
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Support process simulation and recipe testing during commissioning and qualification phases.
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Collaborate with automation and MES teams to ensure process alignment with Batch Logic / ISA-88.
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Participate in Process Studies NPI and PQ execution phases post OQ readiness.
Technical Transfer & Operations Support
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Support tech transfer between manufacturing suites or sites (process/equipment fit gap).
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Collaborate with process development and operations teams for parameter alignment and run readiness.
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Ensure smooth handover to manufacturing with validated robust and compliant systems.
Compliance & Continuous Improvement
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Ensure CQV deliverables meet site and global quality standards.
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Participate in audits walkthroughs and readiness reviews.
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Drive continuous improvement in qualification methodology data management and test efficiency.
Qualifications & Experience
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Degree: Bachelors or Masters in Chemical / Bioprocess / Mechanical / Instrumentation Engineering.
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Experience:
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8 years in biopharma process engineering / CQV.
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Hands-on experience in qualification of process equipment (bioreactors CIP/SIP skids chromatography).
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Strong understanding of process control logic instrumentation and automation interfaces (DeltaV / PLC).
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Knowledge of process flow utilities clean-in-place and sterilization cycles.
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Familiarity with PQ process validation and data trending.
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Knowledge: GxP GAMP5 ISPE Baseline Guides 21 CFR Part 11 Annex 15.
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- Manufacturing
