Responsibilities

• Support process engineering activities for sterile fill-finish and aseptic manufacturing projects.
• Develop and review process design documents, P&IDs, layouts, URS, equipment specifications and technical deliverables.
• Support design and integration of vial filling lines, isolators/RABS, washing, depyrogenation, lyophilisation, capping, visual inspection and packaging interfaces.
• Coordinate with process, mechanical, HVAC, clean utilities, automation, CQV and construction teams.
• Support equipment selection, vendor package reviews, technical queries and design coordination.
• Ensure process designs align with GMP, Annex 1, contamination control, EHS and client requirements.
• Support FAT/SAT, installation, commissioning, qualification readiness and handover activities.
• Work closely with equipment vendors, EPCMV teams, contractors and client stakeholders.
• Track technical actions, risks, changes and project deliverables throughout the project lifecycle.

Requirements

• Process engineering experience within pharmaceutical, biotech or life sciences projects.
• Experience with sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
• Understanding of aseptic process flows, cleanroom zoning, contamination control and hygienic design.
• Knowledge of fill-finish equipment such as vial filling lines, isolators/RABS, lyophilisers, depyrogenation tunnels, cappers, inspection or packaging systems.
• Good understanding of GMP process systems and clean utilities including WFI, clean steam, purified water, compressed air, process gases and CIP/SIP.
• Experience reviewing P&IDs, URS, layouts, equipment specifications and vendor documentation.
• Ability to work across design, construction, commissioning and CQV interfaces.
• Strong coordination, documentation and stakeholder management skills.
• Fluent German and English required.
• Willingness to travel for project requirements.