Director, IT Digital Plant, Manatí Site

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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.

PRINCIPAL OBJECTIVE OF POSITION

Direct and provide leadership to the BMS Manatí Manufacturing Site IT organization. Responsible for the strategic planning, administration and control of integrated IT teams that support the site comprehensive Manufacturing operations. Ensuring that the Manufacturing Execution, Computer System Validation, Process Automation, Projects Execution, and the Data Integrity teams provides an IT service of excellence. Direct site wide actions to comply with BMS corporate wide programs like: Digital Modernization (Lifecycle Management), Cybersecurity, Data Integrity, Automation and MES Standards among others. The position will assure adherence to technology and automation strategies and standards, as well as, compliance requirements. The incumbent will be a regular active member of the Manatí Leadership Team, reporting indirectly to the Site General Manager. Participate in strategic and tactical management activities in relation to IT to provide optimal operations. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES

Direct and lead the Information Technology (IT) Digital Plant Organization for the Manatí site in support of the manufacturing, testing and distribution of pharmaceutical products. Represents IT on the Manatí Leadership Team. He/She is expected to understand and contribute to objectives of the sites beyond direct area of responsibility. Serves as business partner to the plant General Manager. Must demonstrate a thorough understanding of business strategy, objectives, and priorities, and proactively propose innovative technology solutions to fill capability gaps or areas of opportunities. Direct the development and implementation of the Manatí IT strategy that is aligned with both the sites master plan and global IT strategy. Lead for hiring, development, and leadership of staff, continuous improvement of department processes and tools. Responsible for indirect oversight of outsourced IT service providers working on sites such as network and hosting and desktop support personnel. Lead the engagement, empowering, developing, and rewarding a talented and highly dedicated team of IT and Automation professionals supporting a complex and highly regulated manufacturing facilities. Maintains external focus and demonstrates technical expertise and awareness of key industry suppliers and trends across manufacturing and quality systems, process data analytics, and IT service management. Collaborates across site departments and with global IT to develop annual plans, roadmaps, budgets, and project portfolios. Directs and tracks the implementation of projects and initiatives per IT and PMO system lifecycle, program governance, and project management standards (including computer systems validation per GAMP best practices). Collaborates with global IT on local implementation and support of global technology initiatives and systems. Ensures that sites IT personnel, procedures, systems and facilities (site data center) comply with health authority regulatory requirements (e.g., GMP) and internal company policies, procedures, and directives, and are audit ready every day. Accountable for operational and compliance readiness, operational risk reduction, high availability, and business continuity for critical sites infrastructure systems, including data center, voice and data network, and manufacturing execution and control systems. Supports regulatory audits, GMP training, quality investigations and CAPAs, and other quality and compliance activities. Immediately reports issues that could impact product quality. Fosters a safe work environment by championing and adhering to site Health and Safety policies, procedures, and initiatives. Immediately reports unsafe conditions. Serve as a change agent to effectively implement IT solutions and proactively market the skills, capabilities, offerings, and business value provided by the IT organization Direct the design of computerized system in compliance to the technical and compliance requirements required by the GMO Global Strategy. Lead the site Digital Modernization program. Manage the Life Cycle Program associated to Digital Modernization. Sponsor all compliance system related activities at the site, specifically Data Integrity team. Manage the Cybersecurity program for the Manatí Site. Role needs to assure alignment with corporate program office and the consultant firm providing services. Work with site management to prioritize all Digital Plant activities which support improvement projects for the site. Close collaboration with Quality, Manufacturing, OpEx, Project Management and Engineering is required for having effective and sustainable results. Provide status reporting, issue and risk management for the Manatí Site IT organization. Works within a team environment with other Technical services functions, including Engineering and Manufacturing Technology in a matrix organization. Participates in operational strategic and planning meetings. Establishes key performance metrics which monitor and assist the team to understand Information Technology services performance and can be used to improve the productivity and quality of production processes. Manages Information Technology related Exception Reports (e.g. Quality Investigation Reports, CAPA, Change Request Forms, etc.) assuring compliance with Federal and Local Regulatory Agencies (e.g. OSHA, EPA, FDA, DEA, etc.). Participates in regulatory audits as SME and assure areas of responsibility readiness in preparation for inspections and other Regulatory Agencies audits. Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems. Manage the hiring, performance management, training, development and career path and ensure a timely and adequate performance in conformance with cGMP’s, plan procedures, corporate procedures, and applicable regulations (FDA, EMEA, DEA, etc.) of direct reports to maintain a technically competent and customer service oriented work team. Provide career path guidance and development and motivates subordinate personnel to seek professional growth. Assure direct and indirect report colleagues, and external consultants are adequately trained and certified. Develops, coordinates, and maintains a training program together with the plant Knowledge Management Department.

SUPERVISION EXERCISED

BMS Exempt Employees:5 (direct supervised)

Report total number of employees supervised: 34

DECISION MAKING
  • It is expected that the incumbent will make resource allocation decisions/recommendations consistent with priorities, creating new ideas and processes, delivering results, driving for continuous innovation, and demonstrating principled leadership skills.
  • Requires ability to make quick decisions in a high-pressure environment that appropriately balances Operations risks, business value and conformance to IT standards.
  • It is expected that the incumbent will make difficult resources allocation recommendations/ decisions consistent with priorities creating new ideas and processes, delivering results, driving for continuous innovation.
  • Evaluates and approves IT services to be provided by all external IT or automation suppliers to the Bristol-Myers Squibb, Manatí site.
  • Provides guidance for determining work procedures, preparation of work schedule, and expediting of workflow.


B. Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision -
  • Works independently, in process review of performance by supervisor in a matrixed relationship with site GM. Reviews include results and values relating to major assignment.


CONTACTS
  • Inside the Company - Very frequent contact with corporate Global Compliance Assurance management and staff, corporate, local and corporation manufacturing directs, plant managers, department managers, supervisor, exempt, and hourly colleagues, other Bristol-Myers Squibb Co. plants. Corporate GPS IT, and other key manufacturing process stakeholders to support IT services to the manufacturing operation for shift and weekends schedules. Ability to work effectively at all levels of the organization from shop floor personnel and technicians up to the CIO. Frequent interaction with VP level executives
  • External-Contact with Suppliers of hardware, software and services to obtain quotes and for ordering. Local (PR) and external (USA) vendor and suppliers for site support operations. Federal agencies such as Food and Drug Administration FDA, Drug Enforcement Agency (DEA), Pharmaceutical Manufacturers Association and others. To stay updated on current information/validation management developments.


KNOWLEDGE/SKILL
  • Bachelor’s Degree in Science, Computer Science/Technology, or Engineering. Master’s degree in Business Administration, Science or Engineering is preferable.
  • Minimum ten (10) years of experience in IT and a minimum of five (5) years of experience in Parenterals Manufacturing Operations. At least 5 years of people management experience. Experience in a complex global, outsourced IT organization is preferred. Seven (7) years of experience in MES and Automation roles in pharmaceutical manufacturing industry involved in the support of manufacturing systems technologies.
  • Knowledge of Computer Systems validation life cycle methodologies (hardware and software)
  • Strong project management, process improvement, change leadership, system development lifecycle, and IT service management skills. Prefer PMP, PgMP, Six Sigma, and ITIL certifications.
  • Preferred experience implementing and managing applications commonly used in GxP manufacturing plants, such as SAP, Empower, NuGenesis, LIMS, Trackwise, MES, automation control systems, Process Historian, OPC, Kepware, Wonderware, DCA, Factory Talk.
  • Experience with IT data center and network operations desired, along with understanding of manufacturing systems network architecture and ISA-95 control system standards. Knowledge of application infrastructure preferred (databases, SAN, load balancing, middleware, virtualization), along with voice and data networks.
  • Proven skills in project management and support of MES and automation infrastructure and applications in a cGMP-manufacturing environment.
  • Proven experience in management financial budget process and financial health monitoring.
  • Knowledge of SAP/R3 technology infrastructure support highly desirable.
  • Thorough knowledge of cGMP, FDA and EMEA regulations are a must.
  • Excellent communication skills (oral, written and reading) in Spanish and English at all levels
  • Ability to impact and influence people / areas within and outstanding company to deliver business results.
  • Excellent communication skills (oral and written), including ability to fluidly and effectively communicate IT concepts and business value to non-IT people and business concepts to IT people.
  • Ability to work and communicate in a global, culturally diverse, fast-paced matrix team environment. Ability to adapt to changing business needs.
  • Strong analytical capabilities and knowledge of related tools and processes.


WORKING CONDITIONS

A. Describe exposure to any hazards/disagreeable in the work environment:

Normal Office Environmental

Occasional work at Manufacturing Controlled areas like Sterile and Non Sterile processes lines.

B. Travel required (describe nature and frequency):

C. Overnight absences requires (per typical month):

2 to 5

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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