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Senior Reliability Engineer - Lexington Massachusetts
Company: Takeda Pharmaceutical Location: Lexington, Massachusetts
Posted On: 04/26/2024
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Senior Reliability EngineerLocation: Lexington, MAAbout the role:As a Senior Reliability Engineer, you will improve the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Lead reliability-driven actions that require independent and/or collaborative judgment support capital projects. You will report to the Head of Reliability Engineering.How you will contribute: - Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.
- Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.
- Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements.
- CMMS data reliability and integrity improvement.
- Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO.
- Perform functional equivalency assessment of spare parts.
- In collaboration with engineering, manufacturing, and maintenance personnel lead or support troubleshooting of equipment.
- Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA) in cGMP, biotechnology environment.
- Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.
- Participate and provide support for audits.
- Lead the implementation of predictive maintenance across the facility
- Develop business case for improvements requiring investments and participate in capital planning for assigned area.
- Lead, and provide subject matter expertise in the design review and selection of new equipment.
- Interact and support internal Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability.What you bring to Takeda:
- B.S. in Engineering or equivalent work experience.
- 5+ years of relevant work experience.
- Understanding of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable.
- Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable.
- Knowledge of laboratory and pharmaceutical process support equipment including CIP, SIP, Autoclaves, Glass Washers, etc.
- Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics
- Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.
- Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements.
- Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.
- Develop business case for improvements requiring investments and participate in capital planning for assigned area.
- Lead, and provide subject matter expertise in the design review and selection of new equipment.
- Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Perform functional equivalency.
- Author and review sections of regulatory filings and annual product quality reviews.Important ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
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