Maintenance Specialist (R1555382-en-us)
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.
Major Duties and Responsibilities:
1. Ensure Asset Criticality ranking is performed to all area assets and define its maintenance strategy based in the asset criticality.
2. Ensures all critical systems/assets meet customer needs. Implement or propose alterations, modifications, or replacement of existing equipment to reduce maintenance costs, equipment downtime or improve reliability.
3. Responsible and accountable for job plans used for execution of Maintenance in a Biopharmaceutical manufacturing plant. This includes review and approval of all changes to job plans as a result of Feedback to Planner, change control, equipment modification, etc, and ensuring material and task lists are accurate for right first time execution of maintenance activities.
4. Provide support to all maintenance technicians to assist with troubleshooting, act as Subject matter expert for technical questions, and ensure job plans are accurate and able to be safely executed. Ensure vendor completed work meets the necessary maintenance standards and is handed over appropriately. Prepare troubleshooting guides as required by the asset and/or system.
5. Ensure equipment is accessible to all maintenance technicians to ensure safe execution of work. Work with maintenance and EHS teams to develop/revise Job Hazard Analysis (JHA) for PMs and troubleshooting guides. Update both as needed as a result of changes or continuous improvement.
6. Ensures sustainable business process for changes related to job plans, LOTO, and JHA as needed.
7. Own and drive/support operational excellence with regard to Maintenance execution, including cost benefit analysis, review and/or creation of metrics and KPI related to maintenance execution. This may also include working with project engineering to support development of small capital projects to support changes to equipment configuration to support configuration.
8. Develops new systems, practices, policies and procedures pertaining to maintenance and operations activities to enhance the performance of the business.
9. Ensures the application of mechanical and electrical technology, best practices, business trends and how to gain access and implement to maintain level of continuous improvement.
10. Prepares and manages maintenance capital projects for new equipment installations and major equipment overhauls including project scope development, design, procurement, project management up to commissioning and qualification activities.
11. Seeks clear communication with clients to develop the scope, cost and schedule for capital projects as well as develops justification and completes documents required to obtain project approval and to understand specific customer and stakeholder requirements and works across organizational and functional boundaries to assure that customers, peers and support groups have an understanding of the scope and deliverables for all projects.
12. Fosters the understanding of the client/customer needs and integrates the operational support in meeting their requirements.
13. Provides user training and continuous support to assure proper use of the equipment following established operational procedures and manufacturing specifications and sound problem solving techniques to resolve issues and qualification problems.
14. Generates, evaluates and closes change control documentation assuring the validation and compliance state of the equipment.
15. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates.
16. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.
17. Prepares procedures and defines standards for equipment performance optimization.
18. Contact equipment vendors (if applicable) to report problems. Coordinate and implement vendor recommendations when approved or accepted by the area Supervisors or Manager.
19. Understands spare parts needed for routine maintenance and ensures spare parts are available for run to failure equipment. Manage along with STORES the process for replacement of the obsolete parts and storage conditions.
20. For new equipment introduction, works with System Owner, Functional User, project engineering and design engineer or vendor, as needed, to develop necessary training for maintenance technicians, and to develop new maintenance strategy and job plans. This includes that appropriate materials, parts, tools and skill sets are available to accomplish the work safely. May require travel to attend factory acceptance testing (FAT).
21. Works with management on development of sustainable business process for new equipment introduction.
22. Support training of maintenance staff on Techniques, new practices and technologies. This may include review and approval of documents such as work instructions, procedures, and training guidelines used to support work execution and technician training.
23. Works closely with Reliability team to embed Reliability Centered Maintenance (RCM) initiatives to improve the reliability of our systems, equipment and operations. Identify areas of opportunities to optimize equipment and systems using Maintenance Program historical data. Assist with implementation of Predictive Maintenance, and introduction of new technology to support the program, and participate in review of failure tracking and trending for executed work.
24. Ensure program meets necessary compliance requirements. This may include providing evaluation of the Maintenance Program against impacting policies and regulations, support of compliance investigations, CAPA, and change control impact assessments and support of health authority or internal audits.
25. Ensure compliance with EHS guidelines, cGMP regulations, Company policies and other external agency regulations.
26. Support the development of related procedures and programs related to Condition Based Monitoring or maintenance best practices such as Lubrication, precision maintenance and operator driven reliability.
27. Works closely with management on the development of departmental budget.
28. Works closely with Planning and Scheduling to develop standards for major maintenance overhauls and outages, specifically for Shutdown periods.
29. Participate in and lead Root Cause Analysis, Failure Mode and Effects Analysis (FMEA) exercises in conjunction with Reliability Engineer, System Owners, Maintenance Technicians and Manufacturing Operators.
• BS in Engineering (Electrical, Computer, Mechanical, or related fields).
• Six (6) years of experience in manufacturing operations in parenteral pharmaceutical environment. Knowledge of maintenance, operations and engineering generally attained through studies resulting in a B.S., in engineering, related discipline, or its equivalent experience
• A minimum of 6 years of experience in maintenance, engineering or operations of biologic process manufacturing and manufacturing equipment support or equivalent.
• Knowledge of Maximo or other CMMS applications required.
• Demonstrated aptitude for engineering principles and building and/or manufacturing automation systems.
• Experience in working in an environment governed by SOPs and cGMPs and the know-how to work and manage within a regulated environment.
• Adaptable to a fast paced, complex and ever changing business environment.
• Ability to collaborate and work in a team environment; lead small projects and development of maintenance strategies
• Strong analytical and communication skills are critical.
• Willing to provide on call support to a 24/7 manufacturing site, and work nights or weekends when needed to support emergent issue resolution or project implementation.
• Experience in maintenance and or Technical Services, bio pharmaceutical equipment is preferred
• In-depth knowledge of the science and physics involved in the implementation of computerized systems and automation as applied to pharmaceutical production environment.
• Ability to provide support during external and internal regulatory audits (FDA, EMEA, Otsuka, Sanofi, etc.)
• Excellent knowledge of electrical controls theory and electronic circuitry.
• Ability to communicate, collaborate and interact effectively with people with a variety of levels and disciplines including internal and external customers, vendors, contractors and operations staff.
• Ability to exercise good judgment
• Able to read, interprets, and understands electrical/mechanical drawings.
• Ability to analyze equipment design opportunities and to identify and develop technical solutions.
• Technical writing skills.
• Ability to plan and prioritize multiple complex activities simultaneously by using sound Project Management Skills.
• Ability to review SOPs and work instructions
• Flexible and responsible
• Significant ability and aptitude analyzing data to detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
• Bilingual English/Spanish, both written and verbal are required
• Willing to work irregular hours, shifts, weekends and holidays
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.
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