Jobid=591c5173bc11 (0.099)
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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. 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!
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.
Foster strong inter-team relationships to achieve common goals.
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.
Perform revisions of technical documentation content (e.g., investigations, changes, SOPs, and process-related).
Support Technical Product Team, Validation, Development, Operations, QA, and Regulatory in the area of expertise.
Support the Continued Process Verification (CPV) and process monitoring program.
Support health authority and internal inspections.
Other duties as assigned.
Might need to work in shifts
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, KNEAT, etc)
Experience with quality management systems (Veeva vault, Trackwise etc.)
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 . Visit to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
R1599343 : Process Engineer
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