Project Engineer

About the Role

We support a global engineering firm delivering intricate pharmaceutical and biotech projects across Europe and worldwide. Currently, we seek a Project Engineer to aid in the execution of sterile manufacturing projects, focusing extensively on aseptic fill-finish, vial filling operations, cleanroom environments, GMP utilities, and process equipment integration. This position demands bridging engineering disciplines, vendor collaboration, construction, commissioning, and stakeholder communication within regulated pharmaceutical settings.

Key Responsibilities

• Assist in project delivery related to sterile fill-finish and aseptic manufacturing plants.
• Coordinate engineering efforts across process, mechanical, clean utilities, HVAC, automation, CQV, and construction divisions.
• Support the technical execution of vial filling zones, isolators/RABS, washing and depyrogenation processes, lyophilisation, capping, visual inspection, and packaging interfaces.
• Oversee project documentation, manage technical inquiries, maintain action tracking, schedules, and engineering outputs.
• Review design documentation, equipment layouts, user requirement specifications, vendor packages, and inputs to constructability.
• Liaise with vendors, contractors, internal engineering teams, and client representatives.
• Support FAT/SAT procedures, installations, commissioning, qualification preparations, and project handover tasks.
• Ensure compliance with GMP, Annex 1, EHS, quality standards, and client policies during project execution.
• Monitor project risks, modifications, milestones, and technical challenges throughout the delivery phase.
• Provide frequent progress reports to project management and facilitate issue resolution onsite.

Qualifications and Experience

• Proven experience in project engineering within pharmaceutical, biotech, or life sciences projects.
• Hands-on experience with sterile, aseptic, fill-finish, vial, or GMP manufacturing facilities.
• Comprehensive knowledge of cleanroom construction, hygienic design principles, contamination control, and classified production areas.
• Familiarity with fill-finish equipment including vial filling lines, isolators/RABS, lyophilizers, depyrogenation tunnels, capping machines, and inspection or packaging systems.
• Solid understanding of GMP utilities such as WFI, clean steam, purified water, compressed air, process gases, and HVAC systems.
• Experience collaborating with EPCMV teams, equipment vendors, contractors, and client stakeholders.
• Capability to support design, construction, commissioning, and CQV coordination.
• Strong skills in coordination, documentation management, and stakeholder engagement.
• Fluent proficiency in both German and English mandatory.
• Willingness to travel as required for project needs.