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Job Details


Bristol Myers Squibb

Senior Specialist, Operations Technology Systems

Operations

Fermentation Technology

No

Manati, Puerto Rico, United States

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 rich in diversity. 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.

Accountable for providing operational IT support on computerized systems in the Manufacturing, Laboratories/QA, Facilities and Utilities areas including the monitoring and management execution of operational site mission critical systems (like: MES-Syncade, Delta V, Laboratories Information Management System, Empower-Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and standalone computers). Also accountable for the system administration of the computerized systems. 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:

  • Performs preventive/corrective maintenance to all facilities, utilities, and operations equipment automated and computerized systems to assure systems reliability.
  • Provides technical support to critical systems, like MES, Delta V, Empower-Chromatographic Data System, LIMs, databases and others, to assure continuous operations of these computerized systems focused on systems users support. This includes configuration or programming and ongoing maintenance. Works with the site’s Manufacturing, Engineering and Quality Operations Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems.
  • Coordinates with Suppliers of hardware/software and services to obtain quotes, ordering parts and repairs.
  • As a subject matter expert analyses the most technical problems executing and leading System Administration tasks of all computerized systems.
  • Administers on a day-to-day basis the network/systems environment, such as: (1) Add, delete, modify users; (2) add, delete, modify printers and print jobs; (3) verify, create and restore backups; (4) add/remove PCs on the LAN; (5) security administration including granting of file/directory permissions; (6) performance monitoring (7) Database optimization and analysis.
  • Works with IT management and the site’s management in the assessment, recommendation, validation, implementation and administration of computerized systems.
  • Supports system investigations in alignment with corporate directives and site procedures.
  • Maintains all computer base software of all automated facilities/utilities/operations equipment updated and other tasks related with computerized systems. Execute backups, restore and/or disaster recovery process to computrerized systems in accordance with establish procedures. Develops and/or revises maintenance activities plans and spare parts lists for automated equipment to be added into the Computerized Maintenance Management System (CMMS).
  • Writes and reviews operational and safety SOPs or work instructions for computerized systems and system administration; improves and/or develops procedures based on observations and experiences.
  • Prepares reports, fill out records to comply with internal and external regulations.
  • Provides sound problem solving techniques to resolve technical issues and qualification problems.
  • Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
  • Performs process analysis and recommends improvements to existing processes and participates proactively as a team member of implementation projects for new integrated business application and process automation in equipment such as Building Automation System, Delta V, Factory Talk, SCADA Systems and General PLC’s, providing consulting advice in the use and management of technology.
  • Evaluates and closes change control documentation assuring the validated and compliance state of the environments.
  • Serves as a team lead, including, work allocation, quality review and monitoring work progress.

DECISION MAKING:

  • Makes operational critical and timely decisions that will have a direct impact to product quality and compliance by the means of IT Operations. (Operational decisions include operational continuity of direct manufacturing or testing systems, such as, Manufacturing Execution Systems (Syncade) and Laboratory testing systems, like Empower).
  • Sound decision making is required to assure the troubleshooting of applications supporting the manufacturing or quality processes maintain its validated state and keeps the integrity of product and associated process data.
  • Decisions will require taking immediate actions as there could be product lots or testing samples being processed. The average cost of a parenteral biological lot is over 3 million dollars, framing the potential impact of decision making. Decisions require prioritizing, negotiation, independent judgement, resources allocation and development of future corrective actions to avoid recurrent events.
  • Decisions could include immediate actions as the supported systems include manufactuiring during critical steps. Critical steps have predetermined times (or holding times) which establish time constraints before putting at risk the quality of the product or process being supported.
  • Analyzes workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing operations.
  • The incumbent is expected to work independently to accomplish those goals/objectives agreed with IT Management and existing operational procedures, policies and internal controls limit final actions.

KNOWLEDGE / SKILL:

  • BS in Engineering, Electronics or Computer Science/Information Technology.
  • Three (3) years experience in a pharmaceutical operations or Manufacturing processes environment.
  • Two (2) years experience in process automation or laboratory systems.
  • Two (2) years experience in computerized systems.
  • In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment.
  • Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11.
  • Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
  • Experience in the design, development and implementation of infrastructure, MES and Quality Systems.
  • Strong Databases and networking knowledge.
  • Ability to manage and operate computer software packages used for data acquisition systems and PLC programming.
  • Skilled with Microsoft operating systems and MS Office applications.
  • Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc.
  • Ability to troubleshoot problems for highly technical equipment and smart devices.
  • Knowledge of SAP/R3 highly desirable.
  • Experience with external and internal regulatory audits.
  • Broad knowledge of cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
  • Good technical writing skills and ability to review SOPs and work instructions.
  • Effective written and oral communication skills both Spanish and English.
  • Capable to interact with external vendors/customers.
  • Capable to plan work schedules and set priorities with a sense of urgency and meet deadlines.
  • Customer service oriented.
  • Availability to work irregular hours, rotative shifts, weekends and holidays when required due to business needs.
  • Able to plan and prioritize multiple activities simultaneously.
  • Self-starter and well organized.
  • Ability to keep work pace and/or meet deadlines.
  • Ability to exercise good judgment.

WORKING CONDITIONS:

  • Normal Office Environment

Travel required

  • 10% - 25% to review site’s operation and participate in the design, planning implementation and follow up of project

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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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