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 seeking an experienced
Senior CSV Consultant
to join our team and provide expert support on validation activities within regulated environments (GxP). The role involves ensuring that computer systems are compliant with applicable regulatory standards and internal quality requirements, while contributing to the design, execution, and continuous improvement of validation strategies.
Key Responsibilities
* Plan, execute, and document validation activities for computerized systems in compliance with Annex 11, GAMP 5, and 21 CFR Part 11.
* Develop and maintain validation deliverables
* Ensure data integrity principles are implemented and maintained throughout the system lifecycle.
* Participate in the qualification of a new production line, ensuring all computerized systems meet regulatory and internal standards.
* Support Data Integrity gap assessment activities and implement remediation actions where required.
* Collaborate with IT, Quality Assurance, and business stakeholders to ensure compliance.
* Report directly to the Senior CSV Engineer and provide regular updates on validation progress and compliance status.
Qualifications
* Bachelor s degree in Computer Science, Engineering, Life Sciences, or related field.
* 3 years of experience in Computer System Validation within a regulated environment (pharmaceutical, biotech, or medical devices).
* Strong knowledge of 21 CFR Part 11, EU Annex 11, GxP, and GMP regulations
* Hands-on experience with computerized systems (MES, LIMS, PLC, SCADA, lab equipment)
* Skilled in validation activities: URS, IQ, OQ, PQ, UAT documentation
* Experience developing and maintaining DI policies, SOPs, and governance frameworks
* Ability to investigate DI incidents, manage CAPAs, and support audits
* Excellent communication skills and ability to train cross-functional teams
* Fluent in English (mandatory), German language highly preferred
* Strong analytical mindset, attention to detail, and problem-solving skills
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.