Technical Author (a) 100%

The Technical Author position at Bachem Group is focused on developing and maintaining GMP documentation for API manufacturing. The company is expanding its production capacity with a new site in Sisslerfeld, Switzerland, and this role is crucial for ensuring compliant and efficient manufacturing operations. The main responsibilities involve creating, reviewing, and updating GMP documentation, including Manufacturing Instructions, SOPs, and Validation Reports. The role also supports technology transfer and process scale-up, ensuring that production processes are clearly and accurately documented. Additionally, the Technical Author will conduct gap and risk assessments, coordinate documentation activities, and maintain up-to-date GMP documentation during routine operations. They will also support process improvements and investigate complex deviations, implementing and documenting resulting CAPAs. The role requires collaboration with various departments, including Manufacturing, Quality Assurance, Regulatory Affairs, and R&D. To excel in this role, candidates must have a Master's degree or PhD in Chemistry or a related natural science discipline, along with relevant experience in the pharmaceutical industry. Strong German and English language skills, both written and spoken, are essential. The role demands a highly structured, accurate, and detail-oriented working style, with excellent communication and stakeholder management skills. The ability to work independently and manage multiple priorities is also crucial. Nice-to-have skills include experience with MES-based Master Batch Record design or knowledge of PAS-X. The role offers a dynamic and growing work environment with opportunities for professional development and collaboration with senior stakeholders. The Bachem Group provides numerous training opportunities, pension fund contributions, and access to various benefits and sports activities. What the role asks for: - Master's degree or PhD in Chemistry or a related natural science discipline. - Relevant experience in the pharmaceutical industry. - Native-level German and excellent English language skills, both written and spoken. - Highly structured, accurate, and detail-oriented working style. - Excellent communication, stakeholder management, and coordination skills. - Ability to work independently and manage multiple priorities. - Experience with MES-based Master Batch Record design or knowledge of PAS-X (nice to have).