Commission, qualify, and validate pharmaceutical facilities, utilities, equipment, and water systems. Develop and execute CQV protocols, reports, SOPs, and quality documentation while supporting DQ, FAT, SAT, IQ, OQ, PQ, and PV activities. Conduct risk assessments, design reviews, pressure testing, flushing, passivation, sanitization, and lifecycle management for PW and WFI systems. Collaborate with clients, contractors, vendors, and cross-functional teams while ensuring compliance with cGMP and 21 CFR requirements.
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.
- Strong communication, problem-solving, and stakeholder management skills.
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What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
