Manufacturing IT Systems & MES Sr. Specialist

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.

PURPOSE AND SCOPE OF POSITION:

The Manufacturing IT Systems & MES – Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at a multi‐use site through interaction with internal team members, peer and higher-level customers as well as external service providers. This role requires mid-experienced level professionals to maintain system performance and up-time and lead short‐term and long-term IT projects according to established policies and procedures. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. Reporting into the IT organization the candidate will be primarily responsible for driving solutions to manufacturing system related problems including reviewing, planning building, testing, documenting and implementing design changes.

The candidate should have at least 1-3 years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate should possess a strong understanding of shop floor activities, Good Manufacturing Practices (GMPs), and process automation. Very technical knowledge in MS SQL is a must as that skill will be leveraged to develop the candidate into an MES expert. In addition, prior experience in Manufacturing Execution System (MES) use and support is a plus but not required.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Ability to effectively communicate with upper management and site leadership.
• Ability to effectively with both technical and non-technical team members.
• Excellent interpersonal skills, especially regarding:
  • Teamwork and collaboration
  • Client focus
  • Verbal and written communication
  • Strategic thinking
  • Change and Innovation
  • Leadership
• Knowledge of industry standard integration protocols and programming applications such as OPC, BACNet, ODBC, SQL and Web API. Experience using SQL queries to retrieve and manipulate data from large or complex database structures preferred.
• Experience using and supporting MES systems, preferably Emerson Syncade is desirable.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Cell Therapy or Bio-tech manufacturing is desired.
• Ability to understand and review Technical Architecture for computerized Manufacturing systems.
• 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 or similar tools is preferred.
• Understanding of computer system validation. Use of HP ALM or other equivalent testing software.

Education and Experience:

• Bachelor’s degree in an engineering or MIS discipline (advanced degree is preferred).
• Must have 1-3 years of hands-on experience in a biotech manufacturing and supply chain environment.
• Experience with MES, preferably Emerson Syncade, in a bio-tech manufacturing environment is desirable but not required.
• Hands-on experience in designing, building and supporting interfaces between ERP, Quality, MES, Engineering and shop-floor boundary systems is desirable.
• Must have experience implementing, maintaining and/or interfacing with relational databases (SQL).
• Strong working knowledge of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP) is preferred.
• Strong working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily cGxP.
• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) is preferred.

DUTIES AND RESPONSIBILITIES:

• Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the MES, DCS and Historian systems.
• Collaborate with business process leads to design master data, recipes, etc.
• Accountable for operationalizing the manufacturing and peripheral systems.
• Support of manufacturing systems.
• Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR T manufacturing.
• Assist the leadership team with establishing a support organization and Service Level Agreements (SLAs).
• Manage daily operation and future enhancements of MES and lower-level systems as an IT system owner and technical expert.
• Participate in global harmonization of MES implementations, equipment/process and instrument interfaces.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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