Process Engineer API BLA (all genders)

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Position Overview

We are looking for two individuals to support and drive process engineering activities for our Project API insulin manufacturing operations, ensuring compliance with cGMP, HSE, and regulatory (BLA) requirements. Contribute to process development, robustness studies, process validation, and continuous improvement to ensure the performance of biological drug substances (insulin).

Lead equipment packages and systems from Design to qualification.

The API BLA (Biologics License Application) context refers to the regulatory transition of insulin to biologic classification.

Main responsibilities:

• Support manufacturing operations for insulin API (E. coli-based fermentation), including troubleshooting major deviations and driving continuous improvement initiatives
• Contribute to the regulatory transition of insulin as a biologic, supporting BLA submissions and ensuring processes meet regulatory standards
• Drive and support process validation campaigns, robustness studies, and process improvement projects
• Participate in technology transfer activities between R&D CMC and manufacturing, leveraging the co-located R&D site
• Develop and maintain process engineering standards and practices (P&IDs, process models, equipment design)
• Support capital and improvement projects related to insulin API manufacturing
• Work closely with Quality, HSE, Regulatory Affairs, and Production teams

About you

• Education/Experience: advanced Engineering degree (Chemical, Biochemical, Bioprocess, or related field); Experience in pharmaceutical/biopharmaceutical manufacturing, ideally in API or Drug Substance production; experience with process validation and technology transfer in regulated environment; familiarity with E. coli fermentation and downstream processing (chromatography, depth filtration) is a strong asset

• Soft and technical skills: Knowledge of cGMP regulations and biologics regulatory frameworks (BLA/MAA); strong leadership ability to lead equipment packages/systems; highly collaborative, detail-oriented, and resilient in dynamic project environments

• Languages: proficiency in german and English required