Senior Reliability Engineer

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Job Description

Job Title: Senior Reliability Engineer

Location: Lexington, MA

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.

• 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.

• 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.

At 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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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