C&Q Engineer

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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.

As a Commissioning & Qualification (CQ) Expert in Bulk Production, Utilities, and Filling
, you will be responsible for planning, executing, and documenting all commissioning and qualification activities for pharmaceutical manufacturing systems and equipment. You ensure that new or modified systems operate in compliance with GMP and meet all regulatory requirements.

❗The ideal candidate is comfortable to travel in DACH-Area
, depending on the project phase and on-site activity needs.

• Plan and execute Commissioning & Qualification activities for process equipment in Bulk Production, Utilities, and Filling areas.
• Prepare and review CQ documentation such as URS, risk assessments, DQ, IQ, OQ, and related technical documents.
• Support and monitor the commissioning of equipment, systems, and utility supply infrastructures.
• Collaborate closely with Engineering, Production, QA, Automation, and external vendors.
• Identify and assess quality and compliance risks and propose adequate mitigation measures.
• Ensure adherence to GMP, GEP, GAMP5, and relevant regulatory guidelines
  .
• Support deviations, CAPAs, and change controls in the context of qualification projects.
• Coordinate and/or execute FAT/SAT activities and support validation tasks.
• Contribute to continuous improvement of processes, standards, and CQ strategies.

• Degree in Pharmaceutical Sciences, Chemical/Process Engineering, Biotechnology
  , or a comparable field.
• Several years of experience in Commissioning & Qualification within the pharmaceutical industry.
• Strong technical knowledge in process equipment, utilities, clean rooms, or filling processes
  .
• Solid understanding of GMP regulations
  , EU/FDA requirements, and modern science- and risk-based qualification approaches.
• Proficient in working with technical documentation and quality systems.
• Analytical, structured mindset with excellent communication and teamwork skills.
• Very good command of both English and German
• Willing to travel

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.

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.

Mid-Senior level

Full-time

Consulting

Pharmaceutical Manufacturing and Medical Equipment Manufacturing