Project Manager - Melbourne
Core
Coordinate and oversee project execution for commissioning, qualification, and validation (CQV) of facilities, utilities, and equipment in life science manufacturing.
Role type
Senior Project Manager (CQV/Validation)
Builds
Commissioned and qualified facilities, utilities, and filling lines
Domain
Life Science / Pharmaceutical Manufacturing
Required skills
Project management, CQV (Commissioning, Qualification, Validation), GMP/GDP compliance, Risk analysis, System integration, Technical documentation, Cross-functional leadership
Preferred skills
MBA, PMP Certification, Chemical or Mechanical Engineering degree
Technologies
FAT, SAT, IQ, OQ, PQ, PV, DQ, SOPS
Responsibilities
Coordinate internal and external vendors for project execution; Support cost and schedule management across multiple projects; Lead risk analyses, design reviews, and execution of FAT, SAT, IQ, OQ, and PQ; Author and review controlled documents for CQV projects; Write and review GMP/GDP documentation and technical specifications; Partner with cross-functional teams to deliver milestones; Provide mentorship and consultation to clients and internal teams.
Seniority
Senior, hands-on IC