Job Description

Senior Commissioning Qualification Validation Engineer

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Melbourne, Australia | Posted on 08/14/2026

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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."

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- Act as alead and simplify CQV functions, reports, and processes.
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- Supportimplementing safety programs for major capital projects.
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- Commission,qualify, and validate facilities, utilities, and/or equipment in assignedprojects.
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- Initiates,authors, revises, reviews, and completes controlled documents for CQV projects.
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- Reviewand qualify equipment for commissioning, qualification, and validationactivities.
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- Writesand reviews GMP and GDP documents and technical specifications.
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- Collaboratewith multiple departments on assigned project activities and deliverables.
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- Initiateand coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
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- Contactand work with contractors and vendors on assigned projects.
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- Abilityto travel as needed.
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- Additionalduties and responsibilities may be assigned from time-to-time.
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Requirements

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- Bachelor's Degree in Engineeringor Life Science.
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- 7-10 years of applicable workexperience in the biomedical and pharmaceuticals industry.
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- Proficient in authoring andexecuting DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
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- Proficient in developing SOPS,final reports and validation & quality policies.
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- Strong experience developing andexecuting CQV protocols.
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- Robust experience creating andmaintaining CQV policies and processes.
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- Has good understanding andcomplies to cGMPs and CFR21 Part 11 guidelines.
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- 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.
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- Excellent presentation andcommunication skills, written and oral, for a variety of audiences.
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- Highly organized in planning andtime management, with the ability to multi-task.
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📌 Senior Commissioning Qualification Validation Engineer (Victoria)
🏢 PSC Biotech
📍 Victoria