Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .

Following a new opportunity, we are currently looking for an Experienced CQV Engineer with a solid background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in Sydney, New South Wales, Australia.

Key Responsibilities

- Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports.
- Development of Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols for equipment and utilities (e.g., HVAC, Water Systems, Process Gases), according to current internationally recognized guidelines (e.g.,



GAMP).
- Drafting of thermal validation study protocols.
- Risk-based process analysis according to international methodologies.
- Development of calibration and maintenance plans and related instructions.
- Development of standard operating procedures.

About You

- 4-10 years of hands‑on experience in Commissioning and Qualification (C&Q;) within the pharmaceutical, or biotechnology industry.
- Proven experience in FAT, SAT, IQ, OQ, PQ procedures & documentation.
- Strong understanding of GMP principles and risk-based qualification approaches.
- Hands‑on mindset: must be willing and able to actively work with equipment in the field, not just manage documentation.
- Exceptional problem‑solving and leadership skills.
- Fluency in English
- Availability to travel

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📌 Experienced CQV Engineer - Pharma sector (City of Sydney)
🏢 PQE Group
📍 City of Sydney