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.

- Solid communication, problem-solving, and stakeholder management skills.

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