About the Role:

We are seeking a German-speaking Technical Design Lead to join the Capital Projects (CAPEX) team for our client in Bern, supporting fill-finish facility upgrades and expansions. You will work closely with the CAPEX Project Manager and wider engineering team to ensure technical documentation, risk assessments, and project control systems are developed, reviewed, and aligned with strict biopharmaceutical standards.

You will be a critical player during the optimization, shutdown, and startup phases of the project, with a focus on supporting safety, compliance, and operational readiness. This is a high-impact role within a regulated sterile manufacturing (aseptic fill-finish) environment.

Key Responsibilities:

Documentation & Technical Oversight

• Lead the development and validation of risk and safety assessments, including HAZOP, FMEA, and safety concept documentation tailored to fill-finish operations.

• Generate and maintain project controls documentation, including timelines, deliverables, and technical scope.

• Align documentation with GMP, GxP, and global regulatory standards (e.g., FDA, EMA).

Design & Engineering Support

• Act as the interface between engineering, operations, and QA to translate technical requirements into design documentation and implementation plans.

• Ensure proper integration of new equipment or system modifications within existing aseptic filling areas.

• Provide technical input during FAT/SAT and commissioning stages.

 Stakeholder Collaboration

• Work closely with site operators and shift teams (including weekends) to gather operational input and validate safety assumptions.

• Collaborate with cross-functional teams including automation, validation, QA, and production.

• Communicate effectively in both German (mandatory) and English within a multilingual team.

Shutdown & Startup Readiness

• Provide on-site support during critical shutdown windows.

• Ensure all technical documentation is finalized and approved in time for startup.

• Troubleshoot and resolve design-related issues that arise during project execution.

Required Experience & Skills:

• 5+ years of experience in technical design, engineering, or project execution within fill-finish, sterile manufacturing, or biopharma CAPEX projects.

• Strong knowledge of risk assessments, safety documentation, and project control principles in GMP-regulated environments.

• Hands-on experience with cleanroom utilities, aseptic filling lines, and process equipment integration.

• Fluency in German

• Familiarity with serialization, post-serialization processes, and regulatory compliance in secondary packaging (preferred).