Job Description
Are you ready to join a world leader in the exciting and energetic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since ****, with 40 subsidiaries and more than **** employees in Europe, Asia and the Americas.
n
Following a new opportunity, we are currently looking for an Experienced CQV Engineer with a strong background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in Sydney, New South Wales, Australia.
n
Key Responsibilities
n
n
Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports.
n
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).
n
Drafting of thermal validation study protocols.
n
Risk-based process analysis according to international methodologies.
n
Development of calibration and maintenance plans and related instructions.
n
Development of standard operating procedures.
n
n
About You
n
n
4-10 years of hands‐on experience in Commissioning and Qualification (C&Q;) within the pharmaceutical, or biotechnology industry.
n
Proven experience in FAT, SAT, IQ, OQ, PQ procedures & documentation.
n
Strong understanding of GMP principles and risk-based qualification approaches.
n
Hands‐on mindset: must be willing and able to actively work with equipment in the field, not just manage documentation.
n
Exceptional problem‐solving and leadership skills.
n
Fluency in English
n
Availability to travel
n
#J-*****-Ljbffr

📌 Experienced Cqv Engineer - Pharma Sector (New South Wales)
🏢 PQE Group
📍 New South Wales