Location: Germany
Industry: Pharmaceutical / Biotech Engineering
We are supporting an international engineering partner delivering complex pharmaceutical and biotech projects across Europe and globally. The business is looking for a Project Engineer to support sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, cleanrooms, GMP utilities and process equipment integration. This role is suited to someone who can coordinate between engineering disciplines, equipment vendors, construction teams, CQV and client stakeholders within regulated pharmaceutical project environments.
Responsibilities
Support EPCMV project delivery for sterile fill-finish and aseptic manufacturing facilities.
Coordinate activities across process, mechanical, HVAC, clean utilities, automation, CQV and construction teams.
Support project delivery for vial filling lines, isolators/RABS, washing, depyrogenation, lyophilisation, capping, visual inspection and packaging interfaces.
Review technical documents, equipment layouts, URS, vendor packages and project deliverables.
Manage technical queries, action tracking, schedules, risks, changes and project documentation.
Coordinate vendors, contractors, internal engineering teams and client stakeholders.
Support FAT/SAT, installation, commissioning, qualification readiness and handover.
Ensure project execution aligns with GMP, Annex 1, EHS, quality and client requirements.
Provide clear progress updates to project leadership and support issue resolution on site.
Requirements
Project engineering experience within pharmaceutical, biotech or life sciences projects.
Experience with sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
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 working with EPCMV teams, equipment vendors, contractors and client-side stakeholders.
Ability to support design, construction, commissioning and CQV interfaces.
Strong coordination, documentation and stakeholder management skills.
Fluent German and English required.
Willingness to travel for project requirements.
