Process Engineer

About the Role

Join a global engineering organisation specializing in complex pharmaceutical and biotech projects across Europe and worldwide. This position involves supporting sterile manufacturing initiatives in Germany, focusing on aseptic fill-finish operations, vial production, GMP-compliant process systems, clean utilities, and equipment integration.

Key Responsibilities

• Provide process engineering support for sterile fill-finish and aseptic manufacturing projects.
• Prepare and assess process design documentation including P&IDs, layouts, User Requirement Specifications (URS), equipment specifications, and technical deliverables.
• Assist with the design and integration of vial filling lines, isolators and Restricted Access Barrier Systems (RABS), washing, depyrogenation processes, lyophilisation, capping, visual inspection, and packaging interfaces.
• Collaborate with multidisciplinary teams including process, mechanical, HVAC, clean utilities, automation, Commissioning, Qualification, and Validation (CQV), and construction groups.
• Support equipment selection, review vendor packages, manage technical queries, and coordinate design efforts.
• Ensure compliance of process designs with GMP, Annex 1, contamination control protocols, Environmental Health and Safety (EHS) standards, and client specifications.
• Contribute to Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), installation, commissioning, qualification activities, and project handover.
• Maintain communication with equipment vendors, EPCMV teams, contractors, and client stakeholders.
• Monitor and manage technical actions, risks, project changes, and deliverables across all phases.

Candidate Requirements

• Demonstrated experience in process engineering within pharmaceutical, biotech, or life sciences sectors.
• Knowledge of sterile, aseptic, fill-finish, vial or GMP-compliant manufacturing environments.
• Strong understanding of aseptic process flows, cleanroom classifications, contamination control, and hygienic design principles.
• Familiarity with fill-finish equipment such as vial filling lines, isolators/RABS, lyophilisers, depyrogenation tunnels, cappers, inspection, and packaging systems.
• Comprehensive knowledge of GMP process systems and clean utilities including Water for Injection (WFI), clean steam, purified water, compressed air, process gases, and Clean-In-Place/Sterilize-In-Place (CIP/SIP) systems.
• Experience reviewing and interpreting P&IDs, URS, layout plans, equipment specs, and vendor documents.
• Capability to work effectively across design, construction, commissioning, and CQV phases.
• Excellent coordination skills, documentation proficiency, and stakeholder management abilities.
• Fluency in both German and English is mandatory.
• Flexibility to travel as needed for project execution.