Job Information

- Date Opened 08/17/2026
- Job Type Consultant
- Industry Pharma
- City Melbourne
- State/Province Victoria
- Country Australia

POSITION SUMMARY: The Commissioning, Qualification, and Validation (CQV) Engineer (Passivation) is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility.

Key Responsibilities

- Commission, qualify, and validate facilities, utilities, and equipment in accordance with project and regulatory requirements.
- Support the development, review, and execution of CQV documentation, including protocols, reports, and validation deliverables.
- Assists to review and qualify equipment for commissioning, qualification, and validation activities.
- Assist with equipment qualification activities and ensure systems meet design and operational requirements.
- Participate in risk assessments, design reviews, FAT, SAT, IQ, OQ, PQ, and PV activities.
- Collaborate with clients, contractors, vendors, and cross-functional teams to successfully deliver project objectives.





Requirements

Requirements

- Bachelor's Degree in Engineering, Life Sciences, or a related discipline.
- 2+ years of experience in commissioning, qualification, and validation within pharmaceutical, biotech, or regulated environments.
- Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
- Experience developing SOPs, validation reports, and quality documentation.
- Good understanding of cGMP requirements and 21 CFR compliance.
- Previous experience with clean utility systems, particularly Purified Water (PW) and Water for Injection (WFI) systems.
- Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems.
- Knowledge of water system validation, sanitization, and lifecycle management activities.
- Robust communication, problem-solving, and stakeholder management skills.

📌 CQV Engineer (Passivation) (Melbourne)
🏢 PSC Biotech
📍 Melbourne