GMP Technical Author – API Manufacturing

Bachem; Schaffhausen; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

Pension plan

Swibeco platform access

Staff restaurant

Sports facilities

Internal training opportunities

Job summary

Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland, to strengthen API production capacity. We seek a Technical Author to develop, maintain, and assure GMP documentation at our Stein site, interfacing Manufacturing, QA, Regulatory Affairs and R&D.

You will translate complex manufacturing processes into compliant documentation, support tech transfers and process scale-up, and contribute to continuous improvement of operations within a GMP framework.

Qualifications

• Master's or PhD in Chemistry or related natural science field.
• Experience with GMP documentation in pharma or GMP environment.
• Ability to document technical processes clearly and accurately.
• Native-level German with strong English skills.

Responsibilities

• Prepare, review, and maintain GMP documentation for API manufacturing (MIs, SOPs, PVPs, Validation Reports).
• Support tech transfer and scale-up by translating processes into compliant docs.
• Conduct gap and risk assessments and develop concepts and rationales.
• Act as interface between Manufacturing, QA, Regulatory Affairs, and R&D.
• Coordinate documentation activities and ensure timely delivery to internal standards.
• Maintain GMP docs during routine operations in a compliant state.
• Support process improvements and CAPA investigations and documentation.
• Contribute to Master Batch Records in PAS-X MES.

Skills

Structured approach

Stakeholder management

English & German

Education

Master's degree in Chemistry

PhD in Chemistry/Natural science

Tools

PAS-X

GMP documentation tools

Job description

Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland, to strengthen API production capacity. We seek a Technical Author to develop, maintain, and assure GMP documentation at our Stein site, interfacing Manufacturing, QA, Regulatory Affairs and R&D.

You will translate complex manufacturing processes into compliant documentation, support tech transfers and process scale-up, and contribute to continuous improvement of operations within a GMP framework.