Process Validation Specialist

Overview

PQE Group has been at the forefront of the Pharmaceutical and Medical Device industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Job Overview

The Process Validation Specialist will provide critical support in the execution and documentation of process validation activities for OTC products. The role involves ensuring that manufacturing processes are consistently validated, compliant with regulations, and properly documented in both French and English. The ideal candidate will collaborate closely with on-site operators and cross-functional teams.

Responsibilities

• Provide comprehensive documental and process validation support for OTC product manufacturing.
• Prepare, review, and approve process validation protocols, reports, and related documentation.
• Ensure all validation activities comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal standards.
• Collaborate directly with manufacturing operators on-site, requiring clear and effective communication.
• Manage validation projects from planning through to execution and final reporting.
• Support risk assessment activities and investigations related to process performance.
• Maintain validation lifecycle documentation, ensuring timely updates and accuracy.

Working Modality

• Minimum 3 days per week on-site to support manufacturing operations and team collaboration.
• Possibility to perform specific documentation and review activities remotely .
• Mandatory fluency in French for daily interaction with operators and team members.
• Documentation is required partly in French and partly in English .

Required Experience & Profile

We are considering candidates at two different experience levels:

1. Option 1: Experienced Profile —
   • 6–8 years of experience in process validation, quality assurance, or manufacturing within the pharmaceutical or consumer health (OTC) industry.
   • Proven ability to manage validation projects independently, coordinating multiple activities and stakeholders.
   • Strong knowledge of validation principles, cGMP, and relevant health authority regulations.
   • Excellent organizational and communication skills.
2. Option 2: Focused Documentation & Review Profile —
   • 2–3 years of hands-on experience in process validation, document review, or quality control within a GMP environment.
   • Strong attention to detail with a focus on precise document review and preparation .
   • Ability to execute specific validation tasks and support senior team members effectively.
   • Foundational understanding of OTC manufacturing processes.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or a related scientific field.
• Fluency in French (mandatory) and professional proficiency in English .
• Strong IT skills and familiarity with quality management systems.
• Proactive, results-oriented, and capable of working in a dynamic team environment.

Next Steps

1. Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
2. If there\'s a positive match, a technical interview with the Hiring Manager will be arranged.
3. If the Hiring Manager interview is successful, the recruiter will contact you for further steps or to discuss our proposal.
4. If the outcome is negative, we will inform you and close 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.