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 ****
, with
40 subsidiaries
and more than
**** employees in Europe, Asia and the Americas
.
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
.
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.
Solid 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
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation.
PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
#J-*****-Ljbffr

📌 Experienced Cqv Engineer - Pharma Sector (Melbourne)
🏢 PQE Group
📍 Melbourne