- 经验
- 任何
- 薪水
- —
- 职位空缺
- 1
- 发布
- 4小时前
- 工作模式
- 在办公室
- 恢复
- 需要申请
职位描述
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.