Senior Commissioning Qualification Validation Engineer

Melbourne, Australia | Posted on 08/14/2026

We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract . The Senior CQV Engineer is responsible forensuring systems, facilities, and equipment meet design requirements to be putin place for a facility. The incumbent is also responsible and accountable forthe execution of the PSC mission, “to maintain the integrity andprofessionalism of our products and services while enabling steady growth anddevelopment.”

- Act as alead and simplify CQV functions, reports, and processes.

- Supportimplementing safety programs for major capital projects.

- Commission,qualify, and validate facilities, utilities, and/or equipment in assignedprojects.
- Initiates,authors, revises, reviews, and completes controlled documents for CQV projects.
- Reviewand qualify equipment for commissioning, qualification, and validationactivities.
- Writesand reviews GMP and GDP documents and technical specifications.
- Collaboratewith multiple departments on assigned project activities and deliverables.
- Initiateand coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,




- Contactand work with contractors and vendors on assigned projects.
- Abilityto travel as needed.
- Additionalduties and responsibilities may be assigned from time-to-time.

Requirements

- Bachelor’s Degree in Engineeringor Life Science.

- 7-10 years of applicable workexperience in the biomedical and pharmaceuticals industry.

- Proficient in authoring andexecuting DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

- Proficient in developing SOPS,final reports and validation & quality policies.

- Strong experience developing andexecuting CQV protocols.

- Robust experience creating andmaintaining CQV policies and processes.

- Has good understanding andcomplies to cGMPs and CFR21 Part 11 guidelines.

- Demonstrated strategic thinkingand implementation skills; proven analytical skills with ability to translate.Data to actionable plans; demonstrated ability to develop and implementmarketing and product/service. strategies by converting them into tacticalmarketing plans; execute and deliver results.

- Excellent presentation andcommunication skills, written and oral, for a variety of audiences.

- Highly organized in planning andtime management, with the ability to multi-task.

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📌 Senior Commissioning Qualification Validation Engineer (Melbourne)
🏢 PSC Biotech
📍 Melbourne