Senior Process Engineer

About the role

We are seeking a Senior Process Engineer to lead process validation initiatives and support technical transfers from development to commercial‑scale manufacturing. The role operates in a GMP‑regulated environment and requires end‑to‑end ownership of validation deliverables.

Key responsibilities

• Develop, execute, and implement process validation strategies and concepts.
• Support technical process transfers, e.g., from development to commercial‑scale manufacturing.
• Take end‑to‑end ownership of validation deliverables, including concept development, planning, execution, training coordination, sampling, data evaluation, and report generation.
• Plan and coordinate troubleshooting activities with pilot facilities, manufacturing, and quality functions.
• Manage deviations and change controls in compliance with GMP requirements.
• Contribute to continuous improvement and optimization projects.

Required profile

• Degree (or equivalent experience) in biotechnology, bioprocess engineering, chemical engineering, or a related scientific/technical discipline.
• Experience working in a GMP‑regulated environment; exposure to process validation or characterization is advantageous.
• Ability to work independently and collaboratively in cross‑functional teams.
• Comfortable operating in dynamic environments with shifting priorities.
• Strong communication skills and ability to work effectively across cultures.
• Proficiency in German and English.

Required skills

• Process validation
• GMP compliance
• Bioprocess engineering
• Project management (beneficial)

What we offer

• Start date: ASAP
• Contract duration: 6 months (fixed‑term)
• Full‑time workload
• Hybrid work mode with 1–2 days remote per week