GMP Technical Documentation Specialist

Bachem Holding AG; Schweiz; Hybrid; EUR 116.000 - 148.000; Vollzeit

Benefits dieser Stelle

Competitive employee benefits

Professional development opportunities

Zusammenfassung

Bachem Holding AG in Vionnaz, Switzerland, seeks a Technical Author (all) 100% to create and maintain GMP manufacturing documentation, support technology transfer and new product introduction, and help digitize manufacturing records.

You will translate process knowledge into compliant records, collaborate with process scientists, labs, Manufacturing and QA, and contribute to eMBPR implementation. Fluent in French and English; German is a plus; Master’s or PhD; 3–5 years GMP experience.

Qualifikationen

• Master's degree or PhD in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline.
• Strong scientific background with understanding of chemical and pharmaceutical manufacturing processes.
• 3–5 years of experience in a GMP-regulated pharmaceutical or chemical environment.
• Experience in technical writing, manufacturing documentation, technology transfer, or process development.
• Familiarity with batch record creation and document management systems.
• Excellent technical writing skills with attention to detail and a structured approach.
• Fluent in French and English (C1); German a strong asset.
• Proactive team player with good organizational and communication skills.

Aufgaben

• Create, review, and maintain GMP documentation supporting manufacturing operations and technology transfer activities.
• Prepare MBPRs, manufacturing instructions, protocols, reports, and related technical documents.
• Translate process knowledge into compliant, manufacturing-ready documentation.
• Collaborate with Process Scientists, labs, Manufacturing, and Quality Assurance.
• Support technology transfer projects from process familiarization through commercial implementation.
• Participate in new product introduction projects and manufacturing readiness activities.
• Ensure documentation complies with GMP requirements and regulatory expectations.
• Contribute to eMBPR implementation and digitization of manufacturing documentation.

Kenntnisse

Technical writing

Documentation management

Team collaboration

Ausbildung

Master's degree or PhD in Chemistry / Pharmaceutical Sciences / Biochemistry / Chemical Engineering

Tools

Document management systems

Jobbeschreibung

Bachem Holding AG in Vionnaz, Switzerland, seeks a Technical Author (all) 100% to create and maintain GMP manufacturing documentation, support technology transfer and new product introduction, and help digitize manufacturing records.

You will translate process knowledge into compliant records, collaborate with process scientists, labs, Manufacturing and QA, and contribute to eMBPR implementation. Fluent in French and English; German is a plus; Master’s or PhD; 3–5 years GMP experience.