CQV Teach Lead – Commissioning, Qualification & Validation – Life Science

Company: PQE Group

  • Location: Austria
  • Seniority: Senior
  • Employment type: Full-time
  • Posted: 13 days ago
  • Offer language: English

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.

We are looking for an experienced CQV Teach Lead to lead and support our Commissioning, Qualification & Validation activities across multiple projects within the pharmaceutical and life sciences sector in Germany, Austria and Switzerland.

In addition to hands-on technical leadership, you will act as the technical manager and single point of contact (SPOC) for all CQV-related activities. You will oversee the execution of projects, provide technical guidance to the CQV team, ensure consistent application of best practices, and serve as the key interface for clients and internal stakeholders.

‼️Frequent business travel to project sites across Austria is required, depending on project duration and requirements.

You will be responsible for:

  • Act as technical lead and primary point of contact for CQV projects, ensuring technical oversight, GMP compliance, quality, and timely delivery.
  • Lead, mentor, and coordinate CQV engineers and validation resources, harmonizing qualification and validation approaches across projects.
  • Develop and review CQV documentation, including qualification plans, URS, specifications, DQ reports, IQ/OQ/PQ protocols, RTMs, and summary reports.
  • Lead qualification and validation activities for HVAC systems, clean utilities (PW, WFI, clean steam, process gases), temperature mapping, and manufacturing and laboratory equipment.
  • Develop and execute thermal validation studies using GE Kaye Validator systems, data loggers, and relevant testing and calibration instruments.
  • Develop calibration and preventive maintenance plans, procedures, and SOPs.
  • Manage deviations, change controls, periodic reviews, and requalification/revalidation activities.
  • Ensure document traceability, lifecycle documentation, and compliance with GMP, regulatory requirements, and applicable SOPs.
  • Coordinate qualification testing and collaborate with client teams to implement CQV best practices.

About you:

  • Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, or a related field.
  • 6+ years of CQV experience in the pharmaceutical, biotechnology, or life sciences industry.
  • Strong expertise in HVAC and clean utilities qualification, temperature mapping, thermal validation, and GMP-regulated environments.
  • Solid knowledge of ISPE, GAMP, GMP, and FDA/EU regulatory requirements.
  • Proven experience leading technical teams and managing multiple projects.
  • Strong communication, stakeholder management, and client advisory skills.
  • Fluent English and professional proficiency in German (C1/C2) required.
  • Willing to travel

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome 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.

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