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 Manufacturing Engineer to support process validation activities for our pharma clients in DACH. The ideal candidate will have a solid understanding of pharmaceutical validation requirements and documentation standards, playing a key role in ensuring product quality and GMP compliance.
You will be responsible for:
* Execute and support process validation activities.
* Ensure proper validation results through planning, implementation, and analysis of process data.
* Prepare and complete full documentation packages, including:
Validation Plan (VP)
Feasibility / Study protocols
Installation Qualification (IQ)
Test Method Validation (TMV)
Operational Qualification (OQ)
Performance Qualification (PQ)
Validation Report (VR)
* Work closely with cross-functional teams (Engineering, Quality, Production) to gather process data and coordinate validation activities.
* Ensure compliance with internal quality systems and external regulatory requirements (e.g., ISO, GMP).
* Support audits and inspections as required.
About you:
* Bachelor's or Master’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.
* Proven experience in process validation within a regulated manufacturing environment.
* Strong understanding of validation methodologies and documentation practices.
* Experience with article-based validation across multiple processes is preferred.
* Ability to work independently and manage multiple tasks.
* Proficiency in English and German
* Willingness to work on-site by our clients in DACH with flexibility for partial remote work.
Nice to have:
* Knowledge of medical device, pharmaceutical, or automotive manufacturing standards.
* Familiarity with tools such as FMEA, MSA, or Six Sigma.
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.