Key Responsibilities
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* Lead commissioning efforts on systems including (but not limited to): bioreactors and single-use technologies; chromatography columns; clean-in-place (CIP) and steam-in-place (SIP) systems; WFI, clean steam, and process gases; process tanks, skids, and associated piping.
* Conduct impact assessments, risk assessments, and define appropriate qualification strategies.
* Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
* Support and lead the resolution of deviations, non-conformances, and change controls related to commissioning scope.
* Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
* Provide progress updates and contribute to system readiness reviews and handover milestones.
Qualifications
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* Bachelor's degree in engineering, life sciences, or a related technical field.
* Minimum 5 years' experience in commissioning and qualifying large-scale bioprocess equipment; utility systems (WFI, HVAC, compressed gases, clean steam); automation-integrated equipment (DeltaV).
* Deep understanding of commissioning best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
* Experience working on capital projects, preferably from construction to handover.
* Ability to work independently on protocol development, execution, and resolution management.
Requirements
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* Hands-on experience with CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
* Good communication skills and ability to collaborate with cross-functional teams.