Emplois actuels liés à CSV Engineer - ValdeReuil - PQE Group

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.

Due to our constant growth, we are looking for a CSV Engineer to support our projects in Val de Reuil, France

You will be responsible for:

• Work closely with users and maintenance in order to capture As-Is usage and configuration and dispense training (eg. Password usage and maintenance)
• Educate the users and maintenance in applying security to the validated packaging lines
• Create and execute SDLC deliverable for packaging line which include: Validation Plan, Compliance Analysis, Risk Assessment, Configuration Management, User rights matrix, Admin SOP, Training materials for maintenance and users, Backup / Restore and DRP SOP, IQOP test protocol
• Work closely with QA and Business for identification of the CPP and CQA
• Reach the equipment vendor to verify the equipment is configured for optimum compliance
• Liaise with regional CSV SME for alignment with company standards
• Onboard the client systems and come up to speed with the client tools such as Maximo and TRU
• Prepare and execute SDLC deliverables for manufacturing equipment
• Prepare and execute periodic reviews on manufacturing and packaging equipment Working environment

About you:

• Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
• At least 3 years of Computer System Validation or any validation experience required
• Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
• Experience in risk assessments in relation to validation activities
• Smart mindset to interact autonomously with busy shopfloor manufacturing and maintenance people to understand and document how things are done
• Fluent English and French

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.