Experienced CQV Engineer - Pharma sector

PQE Group; City of Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

PQE Group seeks an Experienced CQV Engineer to support projects in Sydney, NSW, Australia. The role focuses on commissioning and qualification in pharmaceutical/biotech environments, with hands-on field work and a strong emphasis on GMP compliance.

You will develop IQ/OQ/PQ protocols, risk-based analyses, and write qualification documentation. Travel availability is required and English fluency is essential to collaborate with global teams.

Qualifications

• 4-10 years of hands-on experience in C&Q within pharma/biotech.
• Proven experience in FAT, SAT, IQ, OQ, PQ procedures & documentation.
• Strong GMP knowledge and risk-based qualification approaches.
• Hands-on field work with equipment and willingness to operate on-site.
• Exceptional problem-solving and leadership skills.
• Fluency in English.
• Willingness to travel.

Responsibilities

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

Skills

C&Q experience

Leadership

Travel willingness

English fluency

Job description

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 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.
• 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

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.