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
