Technical Author Peptide Manufacturing (a), 100% (Temp. 12 Monate) — Bachem AG

Full description

In order to strengthen the existing team in our drug production, we are looking for a dedicated Technical Author Peptide Manufacturing (a), 100% (temporarily for 12 months with a view to acquisition) at the earliest possible time. They are responsible for writing production-relevant GMP documents and in this role are specialized in a production unit (manufacturing cluster).

Their tasks

• Writing, updating and optimizing manufacturing regulations (MBPRs), SOPs, logbooks and risk analyses (FMEAs) for peptide manufacturing.
• Ensuring formal and content document quality according to GMP and internal guidelines.
• Implementation of changes to Master Batch Records (MBRs) in the MES (PAS-X) in close cooperation with the producers.
• Further development and harmonization of document templates and standards to increase efficiency in document creation.
• Close cooperation with the assigned peptide manufacturing cluster and build a deep understanding of manufacturing processes, plants and processes.
• Active participation in process coordination, shop floor visits and exchange with operators, production leaders and chemists to ensure precise and practical documentation.
• Compliance with all relevant GMP, HSE and compliance requirements.
• Ensure the correct implementation of requirements in manufacturing regulations, SOPs and risk analyses.
• Support for internal and external audits by providing the relevant documents and information.
• Active participation in strengthening the GMP and HSE culture in the team and production environment.

Your profile

• Completed university degree in chemistry with a doctorate or a study of natural sciences supplemented by professional experience in the pharmaceutical environment
• German at mother tongue level and excellent English skills
• Mastery of common MS Office tools
• Interest and pleasure in the creation of production-related GMP documents
• Interest in practical processes in the production plant
• Ability to understand complex chemical processes and technical relationships
• Precise operation
• Ability to work independently or in a team due to the situation
• Strong communication and coordination capabilities
• Interested in learning to create Master Batch Records (MBR) in the Manufacturing Execution System (MES) of Bachem (PAS-X). Experience in MBR design in an MES advantageous

Our offer

• A dynamic and rapidly growing working environment with internal development and further education opportunities
• Flexible working hours with the option of home office and the option to purchase additional holidays with reduced workload
• Company-internal KITA on the Bachem Campus Bubendorf
• 60% takeover of pension fund contributions by Bachem AG as well as possibility for over-compulsory provision with our elective savings plan
• Access to advantage platforms with discounts from external partners
• Fresh, healthy and diverse food in our staff restaurant
• Various free sports activities on the Bachem Campus

Do you want to drive innovation together with us?

Have we aroused your interest? Then we look forward to your complete application documents via our application portal.

Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf!