Job Title: Commissioning & Qualification Lead / Project Manager Consultant.
The successful candidate will provide technical support and leadership for new Process Area CAPEX projects. This role requires strong knowledge of biopharma equipment and systems, as well as excellent leadership and communication skills to manage teams and interface with stakeholders.
Key Responsibilities:
* Prior to commissioning drive and track deliverables to completion – engineering and qualification documentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc.
* Support the handover of systems to operations by ensuring all issues are resolved and systems meet operational requirements.
* Oversee onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning.
* Lead the execution of commissioning activities as per pre-approved protocols.
A minimum of 10 years experience in a similar environment is required along with demonstrated expertise in troubleshooting.
The following key skills are essential:
1. Bachelor's degree or equivalent in relevant field;
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2. ()Bioreactors,, chromatography columns,filtration units : -----------------------------------