What type of organization will you join as a Engineer Purified Waters Qualification (M/F)?

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

Mission context

The primary objective of this role is to lead the end-to-end regulatory qualification activities for the purified water system supplying GMP-compliant release testing equipment (Milli-Q system, autoclave, and glassware washer).

The consultant will be responsible for assessing the existing documentation (FAT/SAT), preparing the complete qualification documentation in accordance with internal and regulatory standards, and executing on-site qualification testing to ensure the system achieves full regulatory compliance.

Engineer Purified Waters Qualification (M/F ): What will be your roles and responsibilities?

Working within a results-driven environment, your responsibilities will include:

• Assessment of Existing Documentation: Review and leverage the available technical documentation, particularly FAT and SAT packages, to optimize the qualification strategy.
• Documentation Preparation: Produce the complete set of qualification deliverables using approved regulatory templates, including URS, SIA, FRA, QP, DQ, IQ, OQ, PQ, FS, TM, SRA, CS, and QR.
• Qualification Execution & Testing: Perform on-site qualification testing, analyze collected data, and prepare all appendices required for the qualification report (excluding sampling and chemical analyses).
• Deviation Management: Initiate, investigate, document, propose corrective actions for, and close deviations identified during qualification activities.
• Coordination: Organize and facilitate alignment meetings with project stakeholders and ensure the final consolidation of qualification documentation following review.

What profile and skills are required for this Engineer Purified Waters Qualification (M/F) position?

Experience

• Minimum 5 years of hands-on experience in qualification and validation activities within the pharmaceutical industry.
• Previous experience in utility qualification, particularly purified water systems and water loops, is highly desirable.

Skills & Competencies

• Strong knowledge of cGMP requirements, particularly EU GMP Annex 15 (Qualification and Validation) and Annex 11 (Computerised Systems).
• Excellent technical writing skills for qualification protocols and reports, with proven experience in risk-based quality management, including FRA (Functional Risk Assessment) and SRA (System Risk Assessment).
• Fluent in both French and English, with the ability to write documentation and communicate effectively in both languages.
• Strong attention to detail, excellent organizational skills, high level of autonomy, and the ability to collaborate effectively with multiple remote stakeholders.

Education

• Engineering degree, Master's degree (MSc) in Science or Pharmacy, or Industrial Pharmacist qualification, preferably with a specialization in Quality Assurance, Validation, or Process Engineering.

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 (EHS-MS).

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