Process Engineer – Sterile Fill-Finish Projects
Location: Germany
Industry: Pharmaceutical / Biotech Engineering
Function: Process Engineering / EPCMV Project Delivery
We are supporting an international EPCMV engineering partner delivering complex pharmaceutical and biotech projects across Europe and globally.
The business is looking for a Process Engineer to support sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, GMP process systems, clean utilities and equipment integration.
This role is suited to someone who can support process design, technical coordination and project delivery within regulated pharmaceutical environments.
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.
Key Skills:
Process Engineering | EPCMV | Sterile Manufacturing | Fill-Finish | Aseptic Processing | Vial Filling | P&IDs | URS | GMP Process Systems | Isolators | RABS | Lyophilisation | Depyrogenation | Cleanrooms | WFI | Clean Steam | HVAC | Annex 1 | CQV Interface | Vendor Coordination | German | English
