The project scope involves the full lifecycle from detail design phase all the way through to the commissioning and qualification of the new plant.
Responsibilities:
* Generation User Requirement Specification (URS), reviews and approves system lifecycle documentation, generates FAT, SAT and commissioning protocols.
* Reviews and approves Basis of Design (BOD) and detail design of assigned systems i.e. PFDs, P&IDs etc.
* Tracks HAZOP action items.
* Attends 30%, 60% and 90% model reviews.
* Supervises and executes Site Acceptance Testing (SAT) and commissioning activities.
* Ensures Vendor Document Requirements (VDR) meet requirements.
Education and Experience:
* Bachelor degree in relevant field.
* Experience in pharmaceutical industry.
* Experience with manufacturing process equipment such as Bioreactors, HTST, Viral Filtration, Formulation/filling.
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