Manufacturing Execution System (MES) Engineer - Cell Therapy IT
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Provide central support for site integrated manufacturing execution platform. Assure reliable 24/7 operation of integrated manufacturing systems. Develop methods for maintaining and documenting adherence to BMS policies and procedures for manufacturing and information systems.
Supports the successful operation of the Devens Cell Therapy Manufacturing Execution System (MES) . Reporting into a fast growing IT organization this individual will be responsible for identifying and driving solutions related to the Devens Cell Therapy MES system. This will include designing, building, testing and documenting of solutions and will require a high level of understanding of MES systems and attention to detail. This individual will also be responsible for the development and adherence of MES & IT system governance procedures.
Required Competencies Knowledge, Skills, And Abilities
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding
- Teamwork and collaboration
- Client focus
- Verbal and written communication
- Knowledge of industry standard integration protocols and programming applications such as OPC, ODBC, SQL and Web API.
- Knowledge and experience with MES, preferably Emerson Syncade.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Familiarity with Business Intelligence (BI) and reporting programs including InfoBatch, Crystal Reports, Spotfire, Tableau or similar tools.
- Understanding of computer system validation.
Education And Experience:
- Bachelor’s degree in an engineering or MIS discipline.
- Must have experience with MES, preferably Emerson Syncade, in a bio-tech manufacturing environment.
- Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
- Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
- Must have prior experience working on a project team to implement, customize, or enhance an MES system.
Duties And Responsibilities:
- Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the MES and other Enterprise IT systems.
- Collaborate with business process leads to design master data, recipes, etc.
- Provide support for operationalizing the manufacturing and peripheral systems.
- Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR-T manufacturing.
- Support daily operation and future enhancements of MES and lower-level systems as an IT system owner and technical expert.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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