In what environment will you work as an Equipment Qualification Consultant (M/F)?

We are recruiting, on behalf of one of our clients in the pharmaceutical industry, an Equipment Qualification Consultant (M/F) for a5-month on-site assignment based in the Haute-Garonne department, France.

Mission context

As part of a project involving the revamping and installation of new cold storage equipment (cold rooms, -70°C freezers, -20°C freezers, Cell Bank storage, and blast freezers), the primary objective is to manage qualification activities from start to finish.

The consultant will be responsible for reviewing existing technical documentation (SAT), preparing the full set of regulatory qualification documents (URS, VP, SIA, DQ/IQ/OQ/PQ) in compliance with cGMP requirements (EU GMP Annex 15), executing qualification protocols on-site, and managing deviations, while ensuring timely project delivery and a strong results-oriented approach.

Equipment Qualification Consultant (M/F): What will be your roles and responsibilities?

Reporting to the project team, you will be responsible for all qualification documentation activities as well as the execution of equipment and system qualification.

Your main responsibilities will include:

• Analysis & Qualification Strategy: Review the available technical documentation (including completed SAT documentation) to define the most appropriate qualification strategy.
• Documentation: Prepare and compile all required qualification documentation using approved regulatory templates, including User Requirements Specification (URS), Validation Plan (VP), System Impact Assessment (SIA), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM), Validation Summary Report (VSR)
• On-site Qualification Execution: Prepare and execute qualification protocols within the manufacturing facility for new, refurbished, or second-hand equipment.
• Deviation Management: Identify, document, and investigate discrepancies/deviations encountered during qualification testing, and contribute to associated CAPA investigations.
• Project Management & Reporting: Monitor project progress against a detailed schedule (milestones and deliverables) and provide structured weekly reporting covering risks, deviations, and action plans.

What profile and skills are required for this Equipment Qualification Consultant (M/F) position?

Experience

• Minimum 5 years of successful and relevant experience in equipment validation/qualification within the pharmaceutical or biotechnology industry.
• Demonstrated hands-on experience qualifying utility systems (clean or black utilities) and/or cold storage systems, including freezers, blast freezers, and cold rooms.

Skills & Competencies

• Strong knowledge of cGMP requirements and EU GMP Annex 15.
• Thorough understanding of the validation lifecycle, from URS through VSR, and risk-based validation principles in accordance with ICH Q9.
• Proven ability to work independently with a high level of scientific rigor, quality focus, and attention to detail.
• Strong interpersonal and collaboration skills, with the ability to work effectively with multiple stakeholders across the site.
• Excellent written and verbal communication skills in both French and English.

Education

• Engineering degree, Master's degree (MSc or equivalent), or PharmD, preferably with a specialization in Process Engineering, Chemical/Process Engineering, Pharmaceutical Manufacturing, or Quality Assurance.

Interested in this opportunity? Send us your application!

EP2C Energy is committed to diversity and inclusion. We encourage applications from individuals with disabilities.

As part of our Quality, Health, Safety and Environment (QHSE) policy, we place great importance on compliance with QHSE rules to ensure a safe working environment for our employees, with a strong commitment to environmental responsibility.

Our company is engaged in a continuous improvement approach through its Quality Management System (QMS) and Health, Safety and Environment Management System (HSE-MS).

By joining our teams, you will follow HSE procedures and best practices while contributing to the continuous improvement of our processes.