Technical Author (a) 100%

Bachem; Schaffhausen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Pension plan

Swibeco platform access

Staff restaurant

Sports facilities

Internal training opportunities

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Structured approach

Stakeholder management

English & German

Ausbildung

Master's degree in Chemistry

PhD in Chemistry/Natural science

Tools

PAS-X

GMP documentation tools

Jobbeschreibung

The Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization.

As a Technical Author (a) 100% you will play an important role in developing, maintaining, and ensuring the quality of GMP documentation for API manufacturing at our site in Stein. You will work at the interface between Manufacturing, Quality Assurance, Regulatory Affairs, and R&D and contribute to technology transfer, process scale-up, and the continuous improvement of manufacturing processes. With your structured and detail-oriented approach, you will help ensure compliant, robust, and efficient manufacturing operations.

Your Tasks

• Prepare, review, and maintain GMP documentation for API manufacturing, including Manufacturing Instructions, SOPs, Process Validation Plans, and Validation Reports.
• Support technology transfer and scale-up activities, translating production processes into clear and compliant manufacturing documentation.
• Conduct gap and risk assessments and support the development of appropriate concepts, strategies, and rationales.
• Act as a key interface between Manufacturing, Quality Assurance, Regulatory Affairs, and R&D to align technical and documentation requirements.
• Coordinate documentation activities and ensure the timely delivery of high-quality documentation in line with internal standards and regulatory requirements.
• Maintain GMP documentation in an up-to-date and compliant state during routine operations.
• Support process improvements and the investigation of complex, non-routine deviations, including the implementation and documentation of resulting CAPAs.
• Contribute to the creation and maintenance of Master Batch Records (MBRs) within Bachem's Manufacturing Execution System (PAS-X).

Your Profile

• Master's degree or PhD in Chemistry, or a degree in a natural science discipline combined with relevant experience in the pharmaceutical industry.
• Experience or strong interest in preparing and managing GMP documentation in a pharmaceutical or GMP-regulated environment.
• Ability to understand, describe, and document technical processes and chemical manufacturing processes clearly and accurately.
• Native-level German and excellent English language skills, both written and spoken.
• Highly structured, accurate, and detail-oriented working style with a strong sense of accountability.
• Excellent communication, stakeholder management, and coordination skills, with the ability to work effectively across functions.
• Ability to work independently, manage multiple priorities, and deliver high-quality results within agreed timelines.
• Experience with MES-based Master Batch Record design or knowledge of PAS-X is an advantage; willingness to learn is essential.

Our offer:

• The role offers broad exposure across global Technical Operations and Innovation Platforms and close collaboration with senior stakeholders, enabling strong professional visibility and the opportunity to shape groupwide innovation long-term.
• A dynamic and rapidly growing work environment with internal development opportunities
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the Swibeco benefits platform with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus

Would you like to shape global Operational Readiness frameworks with us?

Learn more about the Bachem Group and our working environment at the Bubendorf site on our website.