Technical Author (a) 100%

Bachem Holding AG; Stein; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Pension plan

Swibeco benefits platform

Staff restaurant

Free sports facilities

Internal training opportunities

Zusammenfassung

Bachem Holding AG is establishing a new site in Stein, Northwestern Switzerland, where the Technical Author will ensure GMP documentation quality for API manufacturing. You will work across Manufacturing, QA, Regulatory Affairs, and R&D to support tech transfer and process scale-up.

The role requires a strong GMP documentation background, German and English proficiency, and the ability to drive compliant documentation in a fast-paced production environment. Learning PAS-X is essential.

Qualifikationen

• Master's degree or PhD in Chemistry or a natural science with pharma experience.
• Experience or strong interest in GMP documentation in pharma or GMP-regulated environment.
• Ability to describe, document, and communicate technical manufacturing processes clearly and accurately.
• Native German and excellent English, written and spoken.
• Structured, precise, accountable, and able to coordinate across functions.

Aufgaben

• Prepare, review, and maintain GMP documentation for API manufacturing (MIs, SOPs, Validation Plans, Validation Reports).
• Support technology transfer and scale-up, translating processes into compliant docs.
• Conduct gap and risk assessments and develop concepts and rationales.
• Interface between Manufacturing, QA, Regulatory Affairs, and R&D to align docs with requirements.
• Coordinate documentation activities and ensure timely, high-quality delivery.
• Maintain GMP docs during routine operations and implement improvements.
• Assist in CAPAs investigations and documentation.
• Contribute to Master Batch Records in PAS-X.

Kenntnisse

German (native)

English (excellent)

Stakeholder management

Documentation writing

Project coordination

Ausbildung

Master's degree or PhD in Chemistry or natural science

Tools

PAS-X

MES Master Batch Records

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