CQV Automated Systems Qualification
1 position — 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): 625–650 €/day
Start date: Automation SAT in September 2026, then OQ shift testing 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: Works within the site's CQV team, alongside the CQV Lead and Cleaning specialist
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 CQV program covering process and buffer equipment. Automated systems on this line require dedicated qualification from Site Acceptance Testing (SAT) through Operational Qualification (OQ), for which the site is recruiting a specialist.
Role summary
As CQV Automated Systems Qualification specialist, you will be responsible for qualifying the automated systems (SIEMENS/PCS7-based) impacted by the project, from the automation SAT phase through to OQ execution and closure.
Key responsibilities
You will perform qualification of automated systems (SAT phase, then OQ) for process & buffer equipment, draft and review SAT protocols and execution reports, run field tests to ensure coverage against protocol requirements, and support the transition from automation SAT into the OQ testing phase.
You will ensure protocol and report quality meets GMP/GxP documentation standards, manage gaps/punch-list items identified during testing to closure, participate in root-cause investigations and impact assessments for identified deviations, and define corrective and/or preventive actions (CAPA) in coordination with the CQV Lead.
You will also coordinate with the equipment/automation supplier on test scheduling and technical queries, report testing progress and technical risks to the CQV Lead and site Quality/Engineering stakeholders, and ensure the project schedule and pharmaceutical compliance requirements are met.
Required experience & qualifications
A minimum of 3 years' effective experience in automated systems qualification within a regulated (pharmaceutical/biotech) environment is required — process/equipment qualification experience is required; laboratory-only qualification experience does not qualify. Hands-on experience with SIEMENS/PCS7 automation platforms is required, along with a solid understanding of GMP/GxP requirements applicable to automated systems qualification. Candidates should be autonomous, organized, and comfortable working directly with suppliers.
Skills required
Expert-level SIEMENS/PCS7 automation platform knowledge and SAT (Site Acceptance Testing) protocol writing & execution are mandatory. Advanced-level OQ testing, deviation/gap & punch-list management, and root-cause analysis & impact assessment are mandatory. Fluent English, written and spoken, is mandatory, and bilingual proficiency in French and English is required. Solid GMP/GxP regulatory knowledge (pharma) is mandatory. Supplier coordination skills are a nice-to-have.
Working schedule
The role covers the automation SAT phase (September), then transitions to OQ shift testing (October). Shift testing is planned to start as of 11/11/2026 (final schedule to be confirmed by the supplier).
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.
