Production Maintenance and Reliability Manager-Sterile Area
- Manatí, Puerto Rico
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.
Accountable for the Engineering services for the parenteral manufacturing area systems to assure production operations continuity and reliability. Provide leadership and support to production maintenance through management of RCM/CMMS teams to satisfy the customer's expectations for equipment performance, maintenance (predictive, preventive and corrective), additions and/or modifications. Manage all maintenance support services within a Reliability Center of Maintenance and Continuous Improvement framework and operation philosophy. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Assures reliability and compliance of all Parenteral manufacturing maintenance activities (e.g., Maintenance work orders, safety inspections, improvement and capital projects, production maintenance support) for BMS Manatí Site by supporting maintenance services activities with other operations leaders and planning personnel.
2. Prepares regular work schedule and matches available employees with varying skills to jobs that must be accomplished routinely and those that arise suddenly and unexpectedly.
3. Provides solution solving techniques and/or troubleshoots routine and unusual problems. Ensures that proper spare parts inventory is available in the stock room and personnel has the necessary skills to complete their tasks.
4. Ensures that all operations in all areas of responsibility are performed in compliance with cGMP Regulations and Company Policies/Procedures, also makes sure that personnel is trained in cGMP's and SOP's.
5. Reviews and authorizes all purchases for the Parenteral Manufacturing and Major Lab equipment (Isolator, Autoclaves, etc.) Maintenance work orders.
6. Participates in operational strategic and planning meetings.
7. Establishes key performance metrics which monitor and assist the team to understand maintenance services performance and can be used to improve the productivity and quality of production processes.
8. Manages resources effectively and efficiently within budgetary constraints and evaluates personnel capabilities to provide adequate training.
9. Evaluates maintenance expense budget and provide base data for budget projection cycle
10. Manages Maintenance-related Exception Reports (e.g., Quality Investigation Reports, CAPA, Change Request Forms, etc.).
11. Complies with Federal and Local Regulatory Agencies (e.g., OSHA, EPA, FDA, DEA, etc).
12. Participates in regulatory audits as SME and assure areas of responsibility readiness in preparation for PAI and other Regulatory Agencies audits.
13. Performs performance appraisals to all personnel under his/her responsibilities following BMS policies and procedures
14. Executes employees' performance improvement plans, development and disciplinary actions as required.
15. Keeps abreast of reliability principles applicable to parenteral Manufacturing Maintenance areas
16. Evaluates and closes change control documentation assuring the validated and compliance state of the environments.
17. Ensures tests to computer systems are performed to determine criticality of component loss, prioritizes importance of components and
Writes recommendations for recovering losses and using backup/restore applicable procedures. Adheres to data integrity and system
security applicable practices under these situations.
18. Read technical journals or manuals and attends vendor seminars or user forums to learn about new computer hardware and software.
19. Supports departmental budget design and control based in site needs and priorities.
20. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established
due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.
21. Ensures an adequate procedural structure to support the systems Life Cycle is available. Defines standards for software automation,
system integration and defines the strategy for plant automation and process integration through an analysis and design/re-design of
current systems and processes.
22. Lead the development and/or reviews for automated systems related procedures such as: Operational, Security, Backup and Restore
and Disaster Recovery.
23. Contacts hardware or software vendors (if applicable) to report problems. Coordinate and implement vendor recommendations when
approved or accepted by the area Supervisors or Manager.
24. Assures reported problems are solved by implementing corrective actions like (but not limited) user retraining, changes to existing SOPs,
applying software fixes or hardware fixes, Information Resources colleagues recommendations, etc. These activities must comply with
current applicable change control procedures.
25. Provides sound problem solving techniques to resolve issues and qualification problems.
26. Assist in the management of Capital Appropriation Requests (CAR's), and timeline of process automation projects and implementation
and support Process Automation initiatives
27. Keeps abreast with current technology.
• BS in Electrical, Mechanical or Computer Engineering or related technical field.
• Eight (8) years of experience in production maintenance in pharmaceutical operations or manufacturing processes with at least five (5) years of experience of supervisory experience.
• Knowledge of cGMP's, SOP's, Federal and local regulatory requirements.
• Proficient in the use of computer software (Work, Excel, Power Point, CMMS, BAS, PLC & Training software packages)
• Proven ability to develop short and long term strategic plans to meet business direction/initiatives and comply with all legal obligations.
• Demonstrated ability to influence and interact at all levels in the organization.
• Ability to balance competing priorities while completing agreed objectives upon projects in a timely manner.
• Fully bilingual (English/Spanish) written and oral.
• Strong negotiating skills with contract services relative to prices and technology
• Strong leadership/management skills
• Strong interpersonal relationship skills
• Proficient knowledge of asset life cycle management, 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.
• In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment as applied to pharmaceutical production environment.
• Experience with external and internal regulatory audits (FDA, EMEA, etc.)
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
• Able to read, interpret, and understand electrical/mechanical drawings.
• Good technical writing skills and ability to review SOPs and work instructions
• Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
• Excellent oral and written communication skills in both English and Spanish.
• Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers' at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
• Self-starter and able to plan and prioritize multiple complex activities simultaneously (i.e.: installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project
• Management Skills.
• Willing to work irregular hours, different shifts, weekends and holidays, when necessary
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.
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