Specialist, MSAT Manufacturing Systems Engineer

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

This function supports the solution intake and design, delivery, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the production of cell therapy products.

Duties/Responsibilities

- Support consistent execution of MES recipe modifications, change controls, and adherence to governing documents related to change management.
- Engage with Site teams (Manufacturing, Quality, Supply Chain, Shared Services, etc.) to support and improve capacity, quality, and cost or to establish root cause.
- Work closely with end users/process owners and subject matter experts to maintain service level expectations across all functions and site systems.
- Work with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for recipe development.
- Provide on-the-floor or remote process support for ongoing manufacturing activities when needed.
- Participate in delivering critical improvements across the manufacturing network through digital technology (e.g., EBR) updates and technical insight.
- Provide MES product impact assessments to support change management, investigations, and product release.
- Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy.
- Lead or assist in designing, testing, and maintaining Electronic Batch Records and related manufacturing data, including, but not limited to, specifications, process parameters, recipes, routings, formulas, process instructions, and process variables.
- Ensuring Recipes/MES are configured for intended use per business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation.
- Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and evolve the process.
- Translate business requirements into functional and design specifications that are compliant, efficient, and effective.
- Support the change initiatives and the implementation of process improvement initiatives.
- Interface with Manufacturing, Quality, Supply Chain, IT, MSAT groups, etc., and serve as applicable Manufacturing System Business Owner.
- Perform process monitoring initiatives, including but not limited to developing and collecting data, analyzing and optimizing the end-to-end process, and anticipating and permanently resolving issues that may arise during production.
- Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports Digital Plant plans and strategies.
- Support Technical Product Team, Validation, Development, Operations, QA, and Regulatory in the area of expertise.

Qualifications

Specific Knowledge, Skills, Abilities:

- Proven experience in building, testing, deployment and maintain and support systems MES (preferably Emerson Syncade), eBR, DeltaV in a regulated pharmaceutical environment.
- Proven experience in cGMP/GMP, ICH guidelines, data integrity, computer system validation and IQ/OQ/PQ of the equipment
- Capable of exercising sound judgment while adapting to rapidly changing priorities
- Demonstrated ability to work in a matrixed structure; focused strongly on stakeholder service and personnel growth.
- Excellent written and presentations skills

Education/Experience/ Licenses/Certifications:

- Bachelor’s degree required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
- Advanced degree preferred.
- 5+ years of relevant work experience is required, preferably in the biotechnology/pharmaceutical or related industry.
- Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition preferred.
- Experience with MES, ERP, DCS, SCADA, LIMS, or other manufacturing and automation boundary systems and technologies preferred.
- Experience with electronic validation systems (Valgenesis)
- Experience with quality management systems (Veeva vault, Trackwise etc.)

#LI-Onsite

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.

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  [email protected] . 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  [email protected] 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.

R1607067 : Specialist, MSAT Manufacturing Systems Engineer