Reliability amp Lifecycle Engineer

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Principal objective of the position:


To provide end-to-end lifecycle engineering support for site manufacturing equipment.


Roles and responsibilities:


Develop new systems, practices, policies and procedures pertaining to maintenance and operations activities to enhance the performance of the business and establish a continuously improving philosophy in reliability.

Ensure new designs and modifications incorporate reliability, availability, maintainability, operability, safety and life cycle costing reviews.

Participates in the development of design and installation specifications along with commissioning/qualification plans.

Participates in the development of criteria for and evaluation of equipment and technical MRO supplier and technical maintenance service providers.

Supports the development of acceptance test and inspection criteria and participates in the final check out of new installations, which includes factory and site acceptance testing that will assure adherence to functional specifications.

Establish equipment criticality ranking and apply PM and PdM tools to critical equipment. Monitor available data to analyze and generate recommendations to Prevent Failures and Out of Tolerance Events.

Manage the Optimization of Calibration Frequencies through calibration interval development worksheet execution.

Support the creation and modification of documentation to support maintenance and calibration activities (Maximo Job Plans, Data Sheets, Work Instructions).

Determine equipment to be monitored and establish the reliability program for predictive maintenance technologies, i.e. laser alignment, thermography, oil analysis, vibration monitoring, ultrasound and the appropriate alarm levels.

Monitor site RCM program performance and publish Asset Health Reports to ensure best practices, benefits, and opportunities.

Prioritize the work activities on the Asset Health Report based on equipment criticality and consequences of the failure.

Lead Failure Mode and Effects Analysis (FMEA) exercises in conjunction with System Owners, Maintenance Operations and Manufacturing Operations.

Review and evaluate the effectiveness of the PM and PdM activities based upon failure mode and effect analysis.

Perform Root Cause Failure Analysis on chronic maintenance to increase reliability and reduce life cycle costs.

Work closely with Planning & Scheduling to schedule, oversee job assignments, and lead PdM contract technicians from a technical perspective.

Supports the development of engineering solutions to repetitive failure and all other problems that adversely affect laboratory operations in the areas of capacity, quality, cost or regulatory compliance issues.

Develop and generate Key Performance Indicators in support of the Reliability program and related projects.

Ensure compliance to all regulatory, GMP, safety and environmental requirements.

Support compliance efforts related to Quality Events, CAPA, change management and contamination investigations.

Support the development and execution of the Site asset replacement strategy for laboratory systems and instruments.

Provide input for departmental budget by allocating expenses bases on site strategies and business unit’s priorities, while assuring compliance with SOX requirements and guarding against budget over runs.


Knowledge and skill:


BS in Engineering (Reliability or Mechanical preferred) and 6 years’ experience (or equivalent) with maintenance and reliability in the Pharma / Biotechnology manufacturing industry.

Ability to manage and organize complex technical projects and familiarity with the manufacturing operations of large scale production facilities as well as GMP experience.

Candidate must have a strong knowledge of preventive, predictive maintenance processes and practices to improve equipment reliability.

Candidate should have knowledge of regulatory, environmental, GMP requirements along with knowledge of manufacturing facilities, utility operations, building maintenance operations.

Expertise with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to scale up and large scale bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers.

Candidate must have knowledge of RCM, CMMS (Maximo preferred) and PdM technology software.

Candidates must be effective in both a team environment and an individual contributor role.

Knowledgeable in engineering principles related to instrumentation in a Biopharmaceutical process troubleshooting.

Candidate must be available for up to 25% percent travel which is likely to occur during future startup operations.

Ability to work extended hours or a modified work schedule as required for coverage of startup activities for future projects and support of ongoing 24/7 operations.


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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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