Associate Director, BI&T Design and Optimization

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 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.

MAJOR DUTIES AND 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.

DECISION MAKING

• 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.

• Works independently, in process review of performance by supervisor together with completion review of major assignments.

KNOWLEDGE/SKILL REQUIREMENTS

• Bachelor’s Degree in Computer Sciences, Computer Software, or Engineering. Master’s degree in Business Administration, Science or Engineering is preferable.

• 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.

WORKING CONDITIONS

• Normal Office Environmental

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

• <5% travel required to review other site’s operation and participate in the design, planning implementation and follow up of some projects.  Also to attend training / industry conferences.

• 2 to 5 overnight absences required (per typical month)

#LI-Onsite

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 [email protected]. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.