Associate Director, BI&T Design and Optimization

Bristol Myers Squibb•Manatí, PR

4d•Onsite

About The Position

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 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. Read more: careers.bms.com/working-with-us. PRINCIPAL OBJECTIVE OF POSITION Direct the design and optimization of BI&T Computerized Solutions for the Manatí Site. Direct site wide actions to comply with BMS corporate wide programs like: Digital Modernization, Cybersecurity, Data Integrity, Automation Standards and MES Standards among others. Responsible for Manufacturing Execution System Development of recipes for all processes at the Manatí Site. Collaborates with other sites MES and Automation (Controls) resources. Be the direct liaison to the site Capital Projects organization and BI&T Planning and Operations organization of Global Manufacturing IT. Serve as site contact to the Cybersecurity Corporate Team. Provide leadership to the team supporting computerized systems of the manufacturing, packaging, laboratories and engineering groups. Responsible for the correct design of IT Solutions, and for IT components on non IT solutions, for the whole site. The position will assure adherence to technology and automation standards, as well as, compliance requirements. Delegation authority to represent Director during planned/unplanned events in the Manatí Leadership Team. Member of the Disaster Recovery Team representing BI&T Department. Participate in financial, strategic and tactical management activities in relation to BI&T 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.

Requirements

Bachelor’s Degree in Computer Sciences, Computer Software, or Engineering.
Knowledge of Computer Systems validation life cycle methodologies (hardware and software)
Seven (7) years of combined experience in MES and Automation roles in pharmaceutical manufacturing industry involved in the support of manufacturing systems technologies.
Three (3) years’ experience of supervision and administrative responsibility
Knowledge in process automation control system technologies like PLC, DCS.
Proven skills in project management and support of MES and automation infrastructure and applications in a cGMP-manufacturing environment.
Knowledge of SAP/R3 technology infrastructure support highly desirable.
Knowledge in the application of S-88 based batch recipe control, Manufacturing Execution Systems, Data Historian, Process Analytical Technology, and integration of systems through S95 and OPC standards.
Ability to understand object-oriented high-level language, such as Visual Basic, as well as of S88 structured batch control logic
Expertise with Microsoft operating systems and MS Office applications
Knowledge of Computer equipment / Operating Systems: Client Server environment, UNIX, Windows, Relational Databases: Oracle, SQL, etc. TCP/IP Network Application
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.
Proficient knowledge of computer system life cycle concepts, change control systems, FDA regulatory requirements, including 21 CFR Part 11 and documentation procedures pertaining to a pharmaceutical manufacturing plant such as cGMP’s, SOP’s, among others.
Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
Good technical writing skills and ability to review SOPs and work instructions
Ability to keep work pace and meet deadlines, exercise good judgment and must have problem solving skills.

Nice To Haves

Master’s degree in Business Administration, Science or Engineering is preferable.

Responsibilities

Direct the design of computerized systems in compliance to the technical and compliance requirements required by Global Strategy.
Lead the site Digital Modernization program and manages resources running the Lifecycle Program associated to Digital Modernization.
Sponsor all compliance system related activities at the site, specifically Data Integrity remediation team.
Liaison with above site Cybersecurity team to ensure implementation of risk mitigation activities for the Manatí Site.
Role needs to assure alignment with corporate program office and the consultant firm providing services.
Design standards for all systems implemented at site. This includes automation, laboratories, applications, data gathering and analysis tools. Infrastructure, and communication standards.
Work with site management to prioritize all BI&T activities which support improvement projects for the site.
Close collaboration with Quality, Manufacturing, QC, 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 BI&T services performance and can be used to improve the productivity and quality of production processes.
Manages applicable BI&T 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.
Lead ISA 95 level 2 and 3 systems support to operations and provides guidance to assure compliance with all regulatory requirements, company policies and procedures.
Work with the Enterprise MES team to define releases, prioritize enhancements and defects for each release, and assist in implementing applicable releases.
As needed, supplement the Shift Support Specialists to provide shift coverage.
Establish, harmonize and maintain the necessary controls (SOPs, Policies and Procedures) to assure BI&T adherence to BMS standards.
Executes employees’ performance improvement plans, development and disciplinary actions as required.
Ensures that system documentation such as: requirements, specifications, drawings, qualification protocols and equipment manuals for the installation are properly maintained and securely kept.
Support the execution, as needed, of the Computer System Validation Compliance program schedule for automated equipment, processes, and systems for the manufacturing operations related to Manufacturing/Engineering/Laboratory, and MES systems such as Periodic Review, User Access Review, Oversight of the execution of compliance program activities related to Data Backup, Disaster Recovery, Business Continuity, and Data Integrity.
Support day to day reliability – hot fixes, upgrades, log file review, vendor bulletins, impact assessments of updates on computerized systems and MES environments and related manufacturing and laboratory systems.
Assist on quality events investigations, CAPA and audit observations 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, 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.
Represent BI&T Department Director during planned/unplanned events in the Manatí Leadership Team, indirectly reporting to General Manager.

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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