Sterile Fill-Finish Engineering Manager (Global Projects)

Project / Engineering Manager – Sterile Fill-Finish Projects
Location: Germany
Industry: Pharmaceutical / Biotech Engineering
An exciting opportunity to join an international engineering organisation delivering complex pharmaceutical and biotech projects across Europe and globally.
We are looking for a Project / Engineering Manager to lead engineering delivery for sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, GMP facilities, process equipment and clean utilities .
This role is suited to someone who can manage multidisciplinary engineering teams, coordinate client and vendor interfaces, and drive project execution across design, construction, commissioning and CQV phases.
Responsibilities

• Lead engineering delivery for sterile fill-finish and aseptic manufacturing projects.
• Manage coordination across process, mechanical, HVAC, clean utilities, automation, CQV and construction teams.
• Oversee project scope, schedules, technical deliverables, risks, changes and engineering milestones.
• Support delivery of vial filling lines, isolators/RABS, washing, depyrogenation, lyophilisation, capping, visual inspection and packaging interfaces.
• Review and manage key project documents including layouts, URS, specifications, vendor packages and design deliverables.
• Coordinate equipment vendors, EPCMV teams, contractors and client stakeholders.
• Ensure project execution aligns with GMP, Annex 1, contamination control, EHS, quality and client requirements.
• Support design reviews, FAT/SAT, installation, commissioning, qualification readiness and handover.
• Provide clear reporting to project leadership and drive resolution of technical and delivery issues.
  

Requirements

• Project management or engineering management experience within pharmaceutical, biotech or life sciences projects.
• Experience delivering sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
• Strong understanding of cleanroom design, hygienic construction, contamination control and classified areas.
• 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 managing multidisciplinary engineering teams, vendors, contractors and client stakeholders.
• Ability to lead project delivery across design, construction, commissioning and CQV interfaces.
• Strong planning, coordination, communication and stakeholder management skills.
• Fluent German and English required.
• Willingness to travel for project requirements.
  

Key Skills
Project Management | Engineering Management | EPCMV | Sterile Manufacturing | Fill-Finish | Aseptic Processing | Vial Filling | GMP Facilities | Isolators | RABS | Lyophilisation | Cleanrooms | WFI | Clean Steam | HVAC | Annex 1 | CQV Interface | Vendor Management | German | English

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