CQV Lead
2 positions — Ref. 130CDC826 — Process & Buffer CQV Program
Location: Alsace region, France (fully on-site, no remote work — exact site address shared with shortlisted candidates)
Client: A global pharmaceutical group specializing in plasma-derived medicines (name disclosed to shortlisted candidates)
Contract type: Freelance / self-employed contractor, long-term assignment (umbrella company / portage entrepreneurial scheme)
Daily rate (TJM): 687–712 €/day
Start date: Training in September 2026, with shift OQ testing beginning in October 2026 (exact dates to be confirmed by the equipment supplier)
Duration: Long-term assignment through project completion (milestone: 11/11/2026, likely extension beyond depending on project phasing)
Team: Reports functionally to the project's CQV coordination; manages a team of 4 people onsite
Language: English required, written & spoken (mandatory — team and documentation are run in English). Bilingual French/English is required.
About the project
The site is running a Commissioning, Qualification & Validation (CQV) program covering process and buffer equipment. To support the ramp-up of Operational Qualification (OQ) activities, the site is reinforcing its CQV team with 4 shift-based teams and is recruiting 2 CQV Leads to structure and manage this effort.
Role summary
As CQV Lead, you will manage and coordinate a team of 4 technicians/engineers through the Commissioning, Qualification and Validation lifecycle of process & buffer equipment, from strategy definition through OQ execution and closure. You will be the main point of contact between your team, the equipment supplier, and the client's Quality and Engineering functions for your area of responsibility.
Key responsibilities
You will lead, coordinate and support a team of 4 people through daily CQV/OQ activities, establish and maintain the workload planning for the team, manage the team's charge/capacity across the shift cycle (mornings/afternoons and nights), and act as escalation point for technical and organizational issues on the floor.
On the technical side, you will define and apply Commissioning/Qualification/Validation strategies for process & buffer equipment, review and draft criticality analyses (impact assessments) of impacted systems, draft, review and approve qualification protocols and execution reports (IQ/OQ), and oversee field test execution to ensure test coverage against protocol requirements.
You will also ensure protocol and report quality meets GMP/GxP documentation standards, track and manage deviations, gaps and punch-list items to closure, participate in root-cause investigations and impact evaluations for identified gaps, and contribute to defining corrective and/or preventive actions (CAPA).
Finally, you will coordinate directly with the equipment supplier on test scheduling and technical queries, report progress and risks to the client's CQV/Quality/Engineering stakeholders, and ensure the project schedule and pharmaceutical compliance requirements are met.
Required experience & qualifications
A minimum of 5 years' effective experience in equipment qualification within a regulated (pharmaceutical/biotech) environment is required — process/equipment qualification experience is required; laboratory-only qualification experience does not qualify. Proven experience leading or coordinating a technical team is required, along with a solid understanding of GMP/GxP requirements applicable to Commissioning, Qualification & Validation, and comfort working directly with equipment suppliers and cross-functional client teams.
Skills required
Expert-level Commissioning, Qualification & Validation (CQV) methodology and protocol & report writing (IQ/OQ) are mandatory, along with advanced team leadership/people management, deviation/gap & punch-list management, root-cause analysis & impact assessment, and planning & workload management. Fluent English, written and spoken, is mandatory, and bilingual proficiency in French and English is required. Solid GMP/GxP regulatory knowledge (pharma) is mandatory. Basic-to-intermediate SIEMENS/PCS7 automation knowledge and SCADA/API architecture familiarity are a nice-to-have.
Working schedule
OQ testing is organized on a shift basis ("Total" cycle, per site scheduling rules): mornings/afternoons Monday to Friday, and nights Tuesday to Saturday, with no Sunday work. Shift work is planned to start as of 11/11/2026.
What we offer
A long-term freelance mission with a major pharmaceutical group, under an umbrella/portage entrepreneurial scheme (no need to set up your own company), fast-track access to the mission, and a competitive daily rate (TJM) as indicated above.
