CQV Lead – Sterile Fill-Finish Projects
Location: Germany
Industry: Pharmaceutical / Biotech Engineering
We are supporting an international EPCMV engineering partner delivering complex pharmaceutical and biotech projects across Europe and globally.
The business is looking for a CQV Lead to lead commissioning, qualification and validation activities for sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, cleanrooms, GMP utilities and process equipment.
This role is suited to someone who can lead CQV strategy, coordinate multidisciplinary teams and drive qualification readiness across design, construction, commissioning and handover phases.
Responsibilities
Lead CQV delivery for sterile fill-finish and aseptic manufacturing projects.
Develop and manage CQV plans, qualification strategies, schedules, protocols and reports.
Coordinate CQV activities across process equipment, clean utilities, HVAC, automation, cleanrooms and facility systems.
Support qualification of vial filling lines, isolators/RABS, washing, depyrogenation, lyophilisation, capping, visual inspection and packaging systems.
Lead FAT/SAT, commissioning, IQ, OQ, PQ readiness, walkdowns, punch lists and system handover.
Work closely with Engineering, Quality, Validation, Automation, Construction, vendors and client stakeholders.
Ensure CQV activities align with GMP, Annex 1, Annex 15, GAMP 5, data integrity, EHS and client requirements.
Manage deviations, change controls, risk assessments, traceability matrices and qualification close-out.
Track CQV milestones, risks, resources and project deliverables.
Provide clear progress reporting and technical leadership to project teams.
Requirements
CQV leadership experience within pharmaceutical, biotech or life sciences projects.
Experience supporting sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
Strong understanding of commissioning, qualification and validation lifecycle requirements.
Knowledge of fill-finish equipment such as vial filling lines, isolators/RABS, lyophilisers, depyrogenation tunnels, cappers, inspection or packaging systems.
Good understanding of GMP utilities including WFI, clean steam, purified water, compressed air, process gases and HVAC.
Experience leading FAT/SAT, IQ, OQ, PQ readiness, walkdowns and handover activities.
Strong knowledge of GMP, Annex 1, Annex 15, GAMP 5, risk-based qualification and data integrity.
Ability to coordinate EPCMV teams, vendors, contractors and client-side stakeholders.
Strong documentation, planning, communication and issue-resolution skills.
Fluent German and English required.
Willingness to travel for project requirements.
Key Skills:
CQV Lead | EPCMV | Sterile Manufacturing | Fill-Finish | Aseptic Processing | Vial Filling | GMP Facilities | FAT | SAT | IQ | OQ | PQ | Annex 1 | Annex 15 | GAMP 5 | Isolators | RABS | Lyophilisation | Cleanrooms | WFI | Clean Steam | HVAC | Qualification | Validation | German | English
