CSV Engineer (Contract/Freelance)

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 .

Following a new opportunity, we are currently looking for a CSV Engineer - Pharma sector (FREELANCERS ONLY)

with a strong background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in Cairo , Egypt .

You’ll be responsible for :

• Reviewing existing validation documentation and GAP assessment findings
• Developing compliance documents to close gaps without full re-validation
• Prioritizing remediation activities across 61 systems (GAMP 3–5)
• Managing remediation tracker and reporting progress
• Supporting validation for manufacturing, packaging, and lab systems
• Assessing data integrity and 21 CFR Part 11 compliance
• Applying a risk-based approach to gap closure and updating risk assessments
• Coordinating with cross-functional teams and vendors

About you:

• Minimum 7 years of experience in Computer System Validation within the pharmaceutical industry
• Deep knowledge of GxP regulations (GMP, 21 CFR Part 11, EU Annex 11)
• Experience with multi-system GAP remediation programs
• Strong documentation and project management skills
• Ability to work independently as a freelancer/contractor
• Excellent communication and collaboration skills in a regulated environment

Availability : 100% on site

Location : Cairo, Egypt

Duration of the project : up to 1 year

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.