Project Manager
Core
Lead cGMP-commissioning, qualification, and validation (C&Q) projects for Life Sciences clients, ensuring operational readiness for process equipment and clean utilities.
Role type
Senior Project Manager (Life Sciences C&Q)
Builds
Commissioning, Qualification, and Validation deliverables for biotech, aseptic processing, and gene therapy facilities.
Domain
Life Sciences / Regulated Industries / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP standards, C&Q project management, regulatory compliance (TGA/global), equipment installation oversight, document control, resource allocation, schedule tracking, change control management, vendor/contractor management, risk assessment, validation protocol design, FAT/SAT coordination, biotech/aseptic process knowledge.
Preferred skills
Automation Project Management experience.
Technologies
21 CFR, URS/FRS/DDS, IOQ/PQ, Validation Protocols, Commissioning Test Plans, Dashboards.
Responsibilities
Provide cGMP leadership for CQV service integration; manage mid-to-large projects for process equipment and clean utilities; lead design reviews and site acceptance; write and approve CQV documents per 21 CFR; support onsite/offsite activities (FATs, SATs, walkdowns); manage change controls and vendor/contractor oversight; allocate resources; track progress and update dashboards.
Seniority
Senior, hands-on IC
