Process Engineer

Bristol Myers Squibb; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Process Engineer to support technology transfer and production of CAR-T products for global clinical trials and commercial supply, based in Leiden. You will act as the process SME, collaborating with Development, Manufacturing and Quality teams to ensure rapid, flawless, compliant, and cost-efficient delivery of quality medicines.

This role requires shifting work to cover ongoing manufacturing campaigns, with occasional travel for training.

Qualifications

• Bachelor's degree in science or engineering (advanced degree preferred).
• 3+ years of biopharmaceutical manufacturing support experience.
• 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.

Responsibilities

• Monitor, analyze, and optimize end-to-end production processes.
• Provide input on process deviations during manufacturing.
• Prepare and approve technical documents (investigations, changes, SOPs, batch records, reports).
• Collaborate with Manufacturing Operations on Shop Floor and Front Line Support during production campaigns.
• Provide prompt input on resolution of events in manufacturing and be responsible for troubleshooting.
• Support change initiatives and implement process improvements; own change controls and MSAT impact assessments.
• Participate in initiatives to ensure safe and compliant cGMP operations.
• Interact with SMEs in the BMS Cell Therapy network to exchange lessons learned.
• Participate in processes being technology transferred into the Leiden Cell Therapy Facility.
• Ability to work in shifts to continuously support manufacturing operations.
• Interact with local teams including MSAT MES, MSAT PDDA, Manufacturing Operations, Quality Assurance and Supply Chain.
• Actively support regulatory inspections as process SME when required.
• Collaborate with cross-functional teams for data collection and interpretation.
• Work with Engineering/Maintenance on new technology and equipment related to production.

Skills

MSAT experience

Process engineering

Single-use technologies

GxP knowledge

Technical writing

Education

Bachelor's degree in science or engineering

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands. The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so‑called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team. Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer! For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

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.
• 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 is required for this position. Occasional travelling for training purposes may be required.

Duties/Responsibilities

• Continuously monitor, analyze, and optimize the end-to-end process and permanently resolve issues that may arise during production.
• Provide technical input and investigation support for process related deviations during manufacturing.
• Author, review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports).
• Interacts with Manufacturing Operations on Shop Floor and in Front Line Support during Production Campaigns.
• Provide prompt input on resolution of events occurring during manufacturing. Responsible for troubleshooting.
• Support the change initiatives and the implementation of process improvement initiatives. Own change controls and change actions and be responsible with MSAT impact assessments.
• Participate in initiatives to ensure safe and compliant cGMP operations.
• Interacts with SMEs in the BMS Cell Therapy network to exchange lessons learned and improve process/operations.
• Participate in the processes being technology transferred into the BMS Leiden Cell Therapy Facility.
• Ability to work in shifts to continuously provide support to manufacturing operations.
• Interact with local teams including MSAT MES, MSAT PDDA, Manufacturing Operations, Quality Assurance and Supply Chain.
• Actively Support regulatory inspections as process SME when required.
• Support internal collaboration with other MSAT functions for data collection, analysis, and interpretation and with cross-functional teams including Manufacturing, Quality Assurance and Supply Chain.
• Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities/equipment related to production process needs.
• Execute test plans and other risk mitigation exercise as part of complex (major and critical) investigations (e.g. Root cause analysis and CAPAs for OOS or batch termination) including lab studies.

Education/Experience/ Licenses/Certifications

• Bachelor's degree in science or engineering (advanced degree is preferred).
• Preferably 3 or more years of manufacturing support or related experience in the biopharmaceutical industry (preferably in MSAT, manufacturing or process development roles).
• 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.

Disclaimer

For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only if you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606320 Process Engineer