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Job Description

Job Title: Reliability Engineer II

Location:  Lexington, MA

About the role:

As a Reliability Engineer II, you will improve the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Engineering. You will lead Reliability Engineering-driven projects that require independent and/or collaborative judgment to work towards optimum equipment availability and effectiveness. 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 PM Optimization to improve the maintenance practices for existing equipment and track success.

• 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 perform or support troubleshooting of equipment.

• Participate in or lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).

• Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in assigned areas.

• Help implement predictive maintenance program across the organization.

• Help prepare and/or participation in technical reviews of equipment design projects.

• May participate in FAT, Commissioning of new and modified equipment.

• Manage contractors as needed.

• Identify cost/waste/energy reduction projects.

• Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations .Measure reliability performance and demonstrate success of improvements.

• Internal: Interacts and supports internal Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability customers.

• External: Work with external equipment and parts suppliers for technical information.  Coordinate vendors for predictive technology use and management.

What you bring to Takeda:

• B.S. in Engineering or equivalent work experience

• 3+ years of relevant engineering experience.

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

• Knowledge of CMMS and engineering and maintenance business practices.

• Experience using MS Office software (Word, Excel and PowerPoint) and MS Project.

• cGMP experience would be ideal.

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

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

• Understanding of predictive technologies and implementation (vibration analysis, thermal imaging, etc.) would be ideal.

• Membership of relevant professional / technical organization would be ideal.

• Familiarity with project management principles would be ideal.

• Knowledge of chemical and biological safety procedures would be ideal.

• 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.

• Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.

• Participate in Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.

• Develop and oversee CAPAs and assess and support change controls.

• Assess and support deviations and GMP investigations.

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

• Functional equivalency assessment of spare parts.

• Identify continuous improvement opportunities and deploy best practices.

• Knowledge of engineering and maintenance functions.

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:

• 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.

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.

#GMSGQ

#ZR1

#LI-MA1

#LI-Hybrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$67,900.00 - $106,700.00

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.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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