Reliability Engineer – 1403544
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Reliability Engineer responsibilities include:
- 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 available data to analyze and generate recommendations to Prevent Failures and Out of Tolerance Events.
- Establish equipment criticality ranking and apply PM and PdM tools to critical equipment.
- Perform Root Cause Failure Analysis on chronic maintenance to increase reliability and reduce life cycle costs.
- 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.
- Manage the Optimization of Calibration Frequencies through calibration interval development worksheet execution.
- Work closely with Planning & Scheduling to schedule, oversee job assignments, and lead PdM contract technicians from a technical perspective.
- Support the creation and modification of documentation to support maintenance and calibration activities (Maximo Job Plans, Data Sheets, Work Instructions).
- Ensure new designs and modifications incorporate reliability, maintainability, operability, and life cycle costing reviews.
- 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.
- Develop and generate Key Performance Indicators in support of the Reliability program and related projects.
- 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 compliance to all regulatory, GMP, safety and environmental requirements.
- Support compliance efforts related to Quality Events, CAPA, change management and contamination investigations.
- 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.
- Bachelor’s in Engineering, Reliability or Mechanical engineering preferred
- Six years experience with maintenance and reliability in the Pharma / Biotechnology manufacturing industry or equivalent.
- Ability to manage and organize complex technical projects and familiarity with the manufacturing operations of large scale production facilities as well as GMP experience.
- Strong knowledge of preventive, predictive maintenance processes and practices to improve equipment reliability.
- 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.
- Knowledge of RCM, CMMS (Maximo preferred) and PdM technology software.
- Effective in both a team environment and an individual contributor role.
- Knowledgeable in engineering principles related to instrumentation in a Biopharmaceutical process troubleshooting.
- 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 start up activities for future projects and support of ongoing 24/7 operations.
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