Senior MES Engineer – PAS‑X Specialist

About the role

The Senior MES Engineer will lead the implementation, support and continuous improvement of our Manufacturing Execution System (PAS‑X) at the Schachen biopharma site. You will work cross‑functionally to ensure MES solutions are aligned with automation, quality and regulatory requirements.

Key responsibilities

• Implement and support MES technical solutions, including PAS‑X recipe management and GMBR design standards.
• Own the integration between PAS‑X and the site automation layer (DeltaV), handling batch integration and data‑flow patterns.
• Support tech‑transfer of process technologies from early‑stage pipelines to GMP operational status.
• Maintain and develop MES GMBRs, master data, electronic batch records and related SOPs.
• Prepare and execute change controls, ensuring compliance with validation and data‑integrity standards.
• Provide MES expertise during investigations, audits and regulatory inspections.

Required profile

• Bachelor’s degree in a life‑science discipline or equivalent practical experience (minimum 5 years in MES).
• At least 3 years in automation or engineering within biologics, pharma or related industries.
• Strong knowledge of computer validation, SDLC (e.g., GAMP 5) and change‑control procedures.
• Proven ability to work cross‑functionally and manage multiple priorities in an English‑speaking environment (C1).

Required skills

• PAS‑X (Werum/Körber) – master recipe, GMBR/MBR design, master data, weigh & dispense, equipment tracking, eRec/eSig.
• DeltaV batch integration and automation interface patterns.
• GAMP 5, Kneat eVal, change‑control and data‑integrity management.
• Electronic batch records, GMP compliance, batch review‑by‑exception concepts.