C&Q Engineer

PQE Group; Deutschland; Hybrid; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A global leader in pharmaceuticals is seeking a Commissioning & Qualification Expert to plan and execute essential qualification activities for manufacturing systems. This role, based in the DACH area, requires solid experience in the pharmaceutical sector, along with a degree in a relevant field and good command of English and German. The expert will ensure compliance with regulations, prepare technical documentation, and monitor commissioning processes in a collaborative environment that promotes innovation and teamwork.

Qualifikationen

• Several years of experience in Commissioning & Qualification within the pharmaceutical industry.
• Strong technical knowledge in process equipment, utilities, cleanrooms, or filling processes.
• Solid understanding of GMP regulations and EU/FDA requirements.

Aufgaben

• Plan and execute Commissioning & Qualification activities for process equipment.
• Prepare and review CQ documentation such as URS, risk assessments, and related technical documents.
• Support and monitor the commissioning of equipment and systems.

Kenntnisse

Commissioning & Qualification

GMP regulations

Process equipment

Analytical skills

English proficiency

German proficiency

Ausbildung

Degree in Pharmaceutical Sciences

Degree in Chemical/Process Engineering

Degree in Biotechnology

Jobbeschreibung

Be among the first 25 applicants

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. The first project will be conducted on‑site in the Central Hesse.

You will be responsible for:

• 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.

About you:

• 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, cleanrooms, 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.

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 from the Hiring Manager interview, the 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Consulting

Industries

Pharmaceutical Manufacturing and Medical Equipment Manufacturing