Sr. Reliability Engineer

Job Title : Senior Reliability Engineer

Location : Lexington, MA

About 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. You will also lead reliability-driven actions that require independent and collaborative judgment to 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 areas of improvement.

• CMMS data reliability and integrity improvement.

• In collaboration with engineering, manufacturing, and maintenance personnel, perform or support troubleshooting of equipment.

• Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA) methodologies to improve equipment that supports manufacturing operations in a cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements.

• Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO.

• Perform functional equivalency assessment of spare parts.

• 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 and measure reliability performance and demonstrate success of improvements.

• Oversee junior staff.

• Support internal Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability customers.

• Work with external equipment and parts suppliers for technical information.

What you bring to Takeda:

• B.S. in Engineering or equivalent work experience.

• 5+ years of relevant work experience.

• Knowledge of CMMS and engineering & maintenance business practices.

• Understanding of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) would be ideal.

• Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA would be ideal.

• cGMP experience would be ideal.

• Knowledge of laboratory and pharmaceutical process support equipment including CIP, SIP, Autoclaves, and Glass Washers would be ideal.

• Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics would be ideal.

• Develop and oversee CAPAs.

• Assess and support change controls.

• Assess and support deviations and GMP investigations.

• Identify continuous improvement opportunities.

• Lead partner audits and regulatory agency inspections for Reliability.

• Author and review responses to inspection observations and agency questions.

Important Considerations

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:

• Be required to wear personal protective equipment (PPE) and other clean room garments daily.

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

• This position requires the ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions.

• Ability to work in a fast-paced environment and handle multiple tasks simultaneously.

• The ability to travel and work across all MA Bio Ops facilities.

• May be required to travel for business reasons, e.g., training and meetings.

• Must be able to work in controlled or clean room environments requiring special gowning.

• Additionally, personal protective equipment must be worn due to safety requirements.

• May work in a cold, wet environment.

• May be exposed to sunlight and heat.

• May be exposed to dust, gases, and fumes.

• Possible exposure to cool/hot storage conditions.

• May be around moving equipment and machinery.

• May be working in a loud area that requires hearing protection and other protective equipment to be worn.

• May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

• May be required to lift, push, pull up to 25 pounds.

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

More about us:

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.