Lead Process Engineer
Listed on 2026-03-06
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Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer, Operations Engineer
A leading global biopharmaceutical manufacturer is delivering a $1.5B bulk manufacturing CAPEX project to expand long-term production capacity. The bulk area is a critical workstream within the facility, and due to overlapping project schedules and constrained internal bandwidth, the project requires an experienced Bulk Operations Subject Matter Expert (SME) to support design review, CQV readiness, and transition to operations.
This role will provide specialist expertise across a complex bulk environment, ensuring design decisions today directly enable efficient commissioning, qualification, and operational readiness tomorrow.
Why This Role Is Critical Impact of Timely Delivery- Accelerates progression to operational readiness
- Reduces CQV duration, rework, and redundant testing
- Optimises system integration across bulk utilities and process equipment
- Increased CQV risk and schedule slippage
- Downstream operational constraints driven by early-stage design gaps
Without strong bulk SME input during design, the project risks avoidable validation delays and execution inefficiencies.
You will support a large-scale bulk operation including:
- 20+ CIP skids
- 40+ vessels
The environment is technically complex, highly integrated, and central to facility performance.
Key Responsibilities- Act as Bulk SME during design review, with heavy emphasis on documentation assessment (P&IDs, URS, design specifications, turnover packages)
- Partner with system owners and stream leads to identify design gaps, integration risks, and CQV impacts
- Influence engineering decisions to mitigate downstream commissioning and qualification challenges
- Support development of an efficient CQV strategy aligned to bulk system complexity
- Collaborate cross-functionally with Process Engineering, CQV, and Operations teams
- Ensure bulk systems are designed for operability, maintainability, and validation efficiency
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