Process Engineer

Process Engineer

BMS - Bristol-Myers Squibb

Leiden, Netherlands

Position Summary

The Process Engineer is responsible for supporting the Technology Transfer and production of BMS CAR-T products for both global clinical trials and commercial supply and for supporting process validation activities.

They serve as the process SME, collaborating with SMEs from the Development, Manufacturing, and Quality teams, while providing key technical support during the technology transfer stage of projects.

The Process Engineer supports the resolution of process deviations, the evaluation and implementation of process changes and provides continuous improvement support to Manufacturing Operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

This position is based in Leiden, The Netherlands. Shift work may be required for this position. Occasional travelling for training purposes may be required

Duties/Responsibilities

• Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility;
• Prepare for and own process validation activities;
• Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production;
• Provide technical input and act as lead investigator for process related deviations, ensuring compliance with internal standards and regulatory requirements;
• Author, review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports);
• Acts as SME and leads interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support. Provide prompt input on resolution of events occurring during manufacturing. Responsible for troubleshooting;
• Support the change initiatives and the implementation of process improvement initiatives. Drive and own change controls and change actions and be responsible with MSAT impact assessments.

Education/Experience/Licenses/Certifications

• Bachelor’s degree in relevant science or engineering discipline. Advanced degree preferred;
• Preferably 5 or more years of manufacturing support or related experience in the biopharmaceutical industry (preferably in MSAT, manufacturing or process development roles);
• Advanced Knowledge of facility/clean room design, process design or equipment, automation;
• Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies;
• Experience with the start-up, process transfer or set up of the new manufacturing facilities.