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Equipment Reliability Specialist

2 months ago

Lexington, Kentucky, United States Takeda Full time

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Position Overview

Job Title: Equipment Reliability Specialist

Location: Lexington, MA

About the Role:

As an Equipment Reliability Specialist, you will enhance the dependability of machinery, utilities, essential systems, and maintenance protocols by utilizing the principles of Reliability Engineering. You will spearhead projects driven by Reliability Engineering that necessitate both independent and collaborative decision-making to achieve optimal equipment performance and availability. You will report to the Head of Reliability Engineering.

Key Responsibilities:
  • Formulate maintenance strategies, plans, standard operating procedures (SOPs), parts lists, bill of materials (BOMs), and schedules for newly introduced and modified equipment.
  • Conduct preventive maintenance optimization to refine maintenance practices for existing machinery and monitor effectiveness.
  • Analyze data from corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics to identify patterns and areas for enhancement.
  • Ensure the reliability and integrity of CMMS data.
  • Collaborate with MRO to enhance the accuracy of Equipment Parts Lists and BOMs.
  • Perform assessments of spare parts for functional equivalency.
  • Work alongside engineering, manufacturing, and maintenance teams to support equipment troubleshooting.
  • Engage in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
  • Lead Reliability Centered Maintenance Improvement (RCM) initiatives or other enhancement projects in designated areas within a cGMP, biotechnology setting.
  • Assist in the implementation of a predictive maintenance program throughout the organization.
  • Contribute to technical reviews of equipment design projects.
  • Participate in Factory Acceptance Testing (FAT) and the commissioning of new and modified equipment.
  • Evaluate reliability performance and demonstrate the success of implemented improvements.
  • Identify opportunities for cost, waste, and energy reduction.
  • Support internal teams in Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability.
  • Collaborate with external suppliers for technical information and coordinate vendors for predictive technology utilization and management.
Qualifications:
  • B.S. in Engineering or equivalent professional experience.
  • 1-3 years of relevant engineering experience.
  • Familiarity with CMMS and engineering & maintenance business practices.
  • Experience in cGMP environments.
  • Knowledge of Reliability Centered Maintenance (RCM) and/or Total Productive Maintenance (TPM) is advantageous.
  • Understanding of laboratory and pharmaceutical process support equipment, including CIP, SIP, Autoclaves, and Glass Washers.
  • Familiarity with process improvement and reliability engineering methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, and FMEA is preferred.
  • Awareness of predictive technologies and their implementation (e.g., vibration analysis, thermal imaging).
  • Membership in relevant professional or technical organizations.
  • Basic understanding of project management principles.
  • Review, improve, and update Maintenance SOPs, Parts Lists, BOMs, and CMMS data integrity for existing equipment.
  • Participate in Reliability Centered Maintenance Improvement (RCM) or other enhancement projects across various areas.
  • Develop and oversee Corrective and Preventive Actions (CAPAs) 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 adhere to strict protocols in our manufacturing facilities to ensure product quality. In this role, you may:

  • Be required to wear personal protective equipment (PPE) and other cleanroom garments daily.
  • Need to remove all makeup, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
  • Communicate clearly and accurately, both verbally and in writing, with a strong understanding of engineering and maintenance functions.
  • Work in a fast-paced environment and manage multiple tasks simultaneously.
  • Travel and work across various facilities.
  • Visually inspect frequently when completing job duties such as drawing verifications, field verifications, equipment verification, spare parts verification, startup, troubleshooting, inspection, and commissioning of equipment.
  • Travel for business purposes, such as training and meetings.
  • Work in controlled or cleanroom environments requiring special gowning.
  • Wear personal protective equipment due to safety requirements.
  • Work in various environmental conditions, including cold, wet, and exposure to sunlight and heat.
  • Be exposed to dust, gases, and fumes.
  • Work in loud areas around moving equipment and machinery that require hearing protection and other safety equipment.
  • Work around chemicals that may require respiratory protection.
  • Work multiple shifts, including weekends, or be asked to work additional hours as necessary.
More About Us:

At Takeda, we are transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs. Takeda is a patient-focused organization that inspires and empowers you to grow through impactful work.

Recognized as a Global Top Employer, Takeda offers rewarding careers, encourages innovation, and strives for excellence in all endeavors. We promote an inclusive, collaborative workplace where our teams are united by a steadfast commitment to delivering Better Health and a Brighter Future to people globally.