C&Q Engineer - Periodic Qualification Reviews
A biopharmaceutical manufacturing site in Northern France is seeking a Commissioning & Qualification (C&Q) Engineer to support periodic qualification reviews of GMP equipment. The role focuses on data collection, documentation, and preparation of periodic review reports for a wide range of production and utility equipment. This is a project‑based assignment requiring strong GMP documentation skills, French fluency, and regular on‑site presence.
Responsibilities
- Support the preparation of periodic qualification reviews for GMP equipment such as isolators, autoclaves, lyophilizers, filling lines, CIP/SIP systems, particle counters, and other process or environmental monitoring devices.
- Gather and organise technical, maintenance, calibration, deviation, and qualification data needed for each review.
- Draft periodic review reports using predefined templates, ensuring accuracy and alignment with regulatory expectations (EU GMP, FDA, Pharmacopoeias, GAMP 5).
- Contribute to the assessment of equipment performance trends and highlight any observations for senior reviewers.
- Document conclusions on equipment qualified state based on available data and established criteria.
- Perform basic regulatory and technical watch activities relevant to equipment qualification.
- Manage document updates, incorporate stakeholder comments, and support approval workflows.
- Participate in project meetings and provide progress updates and meeting notes when required.
- Work regularly on site in Northern France for data collection, with remote work possible for drafting and analysis.
Requirements
- Minimum 2-3 years of experience in C&Q, CQV, or equipment qualification within a biopharmaceutical GMP environment.
- Solid understanding of cGMP requirements (EU GMP, FDA, BPF) and qualification principles.
- Experience drafting qualification or periodic review documentation.
- Fluent French speaker, able to interact with site teams and produce documentation in French when needed.
- Ability to work regularly on site in Northern France.
- Familiarity with a range of GMP equipment (isolators, autoclaves, lyos, filling lines, CIP/SIP, environmental monitoring equipment).
- Up‑to‑date GMP training (within the last 12 months) with traceable proof.
- Strong analytical, organisational, and communication skills.
- Comfortable working independently while collaborating with project stakeholders.
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