GMP Documentation Specialist (m/w/d)

Role Overview

Join a dynamic, fast-paced biopharmaceutical environment to support clinical biologics manufacturing within the Manufacturing Operations team. This position is embedded in the Operational Excellence team, focusing on right-first-time execution, documentation robustness, and efficient record lifecycle management. You will work closely with shop floor teams, manufacturing subject matter experts, and Quality to ensure operational reviews of executed batch records meet ALCOA+ standards and GMP expectations across both paper-based and Electronic Batch Records (EBR).

Key Responsibilities

• Executed Batch Record Review:
  • Perform operational review of executed batch records for clinical biologics manufacturing, including Upstream Processing (USP), Downstream Processing (DSP), Weighing & Dispense (W&D), and solution preparation (buffers, media).
  • Review paper-based batch records and EBR for ALCOA+, data integrity, and GDP compliance.
  • Review executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs.
  • Identify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams.
  • Support right-first-time execution and continuous improvement of documentation practices.
• Documentation Creation & Lifecycle Support:
  • Support the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality.
  • Contribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms.
  • Support implementation of documentation updates into manufacturing operations.
• Deviation & Correction Support:
  • Support documentation-related deviations, corrections, and clarification activities.
  • Provide input and supporting documentation for deviation investigations related to manufacturing records.
• Document Handling & Archiving:
  • Issue and control floor copies of approved batch records and manufacturing documents.
  • Support GMP-compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures.
  • Ensure traceability and version control of manufacturing documentation throughout the document lifecycle.

Required Qualifications

• Bachelor’s degree or equivalent experience in life sciences, biotechnology, engineering, or a related field.
• Experience working in a GMP manufacturing environment, preferably biologics.
• Hands-on experience with batch record review, manufacturing documentation, or shop-floor support.
• Solid understanding of GDP principles.
• Experience with paper batch records and/or Electronic Batch Records (EBR).

Preferred Qualifications

• Experience in clinical manufacturing environments.
• Familiarity with USP / DSP operations.
• Experience with W&D and solution/media preparation documentation.
• Exposure to MES / EBR systems (e.g. PAS-X, Syncade).

Key Skills & Competencies

• Strong attention to detail and structured working style.
• Ability to work cross-functionally with Process Operations, Tech Transfer, Process MES, and Quality.
• Strong written documentation and technical writing skills.
• Proactive mindset with focus on process robustness and continuous improvement.
• Strong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP-relevant documentation.

Additional Information

• Temporary contract duration: 26/10/2026 until 30/06/2027.
• Onsite role.