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 a
Senior CQV Engineer
with a strong background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in
Melbourne
, Victoria 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.
Requirements
* 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
* Full availability for international relocation and travel.
Next steps
Upon receiving your application, if a match is found, the Talent Acquisition department will contact you for an initial HR interview. If there is a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.
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. Apply now and take the first step towards an amazing future with us.