Job Description

POSITION SUMMARY :

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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 for
n ensuring systems, facilities, and equipment meet design requirements to be put
n in place for a facility. The incumbent is also responsible and accountable for
n the execution of the PSC mission, “to maintain the integrity and
n professionalism of our products and services while enabling steady growth and
n development.”

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- Act as a
n lead and simplify CQV functions, reports, and processes.

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- Support
n implementing safety programs for major capital projects.

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- Commission,
n qualify, and validate facilities, utilities, and/or equipment in assigned
n projects.

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- Initiates,
n authors, revises, reviews, and completes controlled documents for CQV projects.

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- Review
n and qualify equipment for commissioning, qualification, and validation
n activities.

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- Writes
n and reviews GMP and GDP documents and technical specifications.

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- Collaborate
n with multiple departments on assigned project activities and deliverables.

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- Initiate
n and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,

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- Contact
n and work with contractors and vendors on assigned projects.

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- Ability
n to travel as needed.

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- Additional
n duties and responsibilities may be assigned from time-to-time.

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Requirements n

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- Bachelor’s Degree in Engineering
n or Life Science.

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- 7-10 years of applicable work
n experience in the biomedical and pharmaceuticals industry.

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

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

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- Robust experience developing and
n executing CQV protocols.

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- Strong experience creating and
n maintaining CQV policies and processes.

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

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- Demonstrated strategic thinking
n and implementation skills; proven analytical skills with ability to translate.
n Data to actionable plans; demonstrated ability to develop and implement
n marketing and product/service. strategies by converting them into tactical
n marketing plans; execute and deliver results.

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

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- ​Highly organized in planning and
n time management, with the ability to multi-task.

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📌 Senior CQV Engineer - Brisbane
🏢 PSC Biotech
📍 Brisbane