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Reliability Engineer I
2 months ago
Job Description
Job Title : Reliability Engineer I
Location : Lexington, MA
About the role:
As a Reliability Engineer I, you will improve the reliability of equipment, utilities, critical systems, and maintenance processes by applying the principles of Reliability Engineering. You will also lead Reliability Engineering-driven projects that require independent and 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 lead to support troubleshooting of equipment.
Participate in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in assigned areas in a cGMP, biotechnology environment.
Help implement predictive maintenance program across the organization.
Help prepare and/or participate in technical reviews of equipment design projects.
May participate in FAT, Commissioning of new and modified equipment.
Measure reliability performance and demonstrate the success of improvements.
Identify cost/waste/energy reduction projects.
Interact and support internal Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability customers.
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.
1-3 years of relevant engineering experience.
Knowledge of CMMS and engineering & maintenance business practices.
cGMP experience.
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, and Glass Washers.
Understanding of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA would be ideal.
Understanding of predictive technologies and implementation (vibration analysis, thermal imaging).
Membership of relevant professional / technical organization.
Familiarity with project management principles.
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.
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.
Identify continuous improvement opportunities.
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:
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, and 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, 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 visually inspect frequently when completing the following job duty: drawing verifications, field verifications, equipment verification, spare parts verification, startup, troubleshooting, inspection, and commissioning of equipment.
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.
May be working in a loud area around moving equipment and machinery 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.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
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