Lead Reliability Engineer

2 weeks ago

Lexington, Kentucky, United States Takeda Pharmaceutical Company Ltd Full time


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 Privacy Notice and Terms of Use.

I further attest that all information I submit in my employment application is true to the best of my knowledge.


Job Description Job Title :
Lead Reliability Engineer

Location :
Lexington, MA

About the role:

As a Lead Reliability Engineer, you will enhance the dependability of machinery, utilities, essential systems, and maintenance procedures by utilizing the principles of Reliability Centered Maintenance.

You will also spearhead reliability-focused initiatives that necessitate both independent and collaborative decision-making. You will report to the Head of Reliability Engineering.

How you will contribute:
- Formulate the maintenance strategy, plans, standard operating procedures (SOPs), parts lists, bill of materials (BOMs), and schedules for new and modified equipment.

- Conduct reviews, enhancements, and updates of Maintenance SOPs, Parts Lists, BOMs, and ensure the integrity of CMMS data for existing equipment.

- Analyze data from corrective work orders in CMMS and Quality Event Metrics to discern trends and pinpoint areas for improvement.

- Improve the reliability and integrity of CMMS data.

- Collaborate with engineering, manufacturing, and maintenance teams to troubleshoot equipment issues.


- Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA) methodologies to enhance equipment supporting manufacturing operations in a cGMP, biotechnology environment.

- Measure reliability performance and demonstrate the success of enhancements.

- Improve the accuracy of Equipment Parts Lists and BOMs in collaboration with MRO.

- Conduct functional equivalency assessments of spare parts.

- Lead Reliability Centered Maintenance Improvement (RCM) or other enhancement projects across various domains.

- Participate in and provide support for audits.

- Oversee the implementation of predictive maintenance throughout the facility.

- Develop business cases for enhancements requiring investments and engage in capital planning for the assigned area.


- Provide subject matter expertise in the design review and selection of new equipment, measuring reliability performance and demonstrating the success of improvements.

- Mentor junior staff.

- Support internal Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability stakeholders.

- Collaborate with external equipment and parts suppliers for technical information.

What you bring to Takeda:
- B.S. in Engineering or equivalent professional experience.

- 5+ years of relevant professional experience.

- Familiarity with CMMS and engineering & maintenance business practices.

- Understanding of Reliability Centered Maintenance (RCM) and/or Total Productive Maintenance (TPM) is preferred.


- Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, and FMEA is advantageous.

- cGMP experience is preferred.

- Familiarity with laboratory and pharmaceutical process support equipment including CIP, SIP, Autoclaves, and Glass Washers is beneficial.

- Understanding of core engineering principles such as heat transfer, mass transfer, thermodynamics, and fluid mechanics is advantageous.

- Develop and oversee Corrective and Preventive Actions (CAPAs).

- Assess and support change controls.

- Evaluate 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 inquiries.

Important Considerations:
At Takeda, our patients rely on us to deliver quality products.

As a result, we must adhere to strict regulations in our manufacturing facilities to ensure we maintain the quality of our products.


In this role, you may:
- Be required to wear personal protective equipment (PPE) and other clean room garments daily.

This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets, gloves, and hearing protection.

- 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, both verbally and in writing, along with a strong understanding of engineering and maintenance functions.

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

- The ability to travel and work across various facilities.


The candidate will be expected to evaluate and prioritize activities to support the business and add value to the company.

- May be required to travel for business purposes, such as 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 work 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, or 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.

#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:
$84,000.00 - $132,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S.

based employees may be eligible for short-term and/or long-term incentives.

U.S.

based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S.

based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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
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