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Junior Reliability Specialist

2 months ago

Lexington, Kentucky, United States Takeda Pharmaceuticals Full time

Job Title :
Junior Reliability Specialist

Location :
Lexington, MA

About the Position:

In the role of Junior Reliability Specialist, you will enhance the dependability of machinery, essential systems, and maintenance protocols by utilizing the principles of Reliability Engineering.

Your responsibilities will include spearheading 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 inventories, bill of materials (BOMs), and maintenance frequencies for both new and modified equipment.
- Conduct preventive maintenance optimization to refine maintenance practices for existing machinery and monitor outcomes.
- Analyze data from corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics to detect trends and identify areas for enhancement.
- Ensure the reliability and integrity of CMMS data.
- Collaborate with the Maintenance, Repair, and Operations (MRO) team to enhance the accuracy of Equipment Parts Lists and BOMs.
- Execute functional equivalency assessments of spare components.
- Collaborate with 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 (RCM) improvement initiatives or other enhancement projects in designated areas within a cGMP, biotechnology context.
- Assist in the implementation of a predictive maintenance program throughout the organization.
- Contribute to and/or participate in technical evaluations of equipment design projects.
- May take part in Factory Acceptance Testing (FAT) and the commissioning of new or modified equipment.
- Measure reliability performance and demonstrate the success of implemented improvements.
- Identify opportunities for cost, waste, and energy reduction.
- Collaborate and support internal teams in Manufacturing, Facilities, Engineering, Validation, Quality, and Reliability.
- Work with external suppliers for technical information and coordinate vendors for predictive technology management.

Qualifications:
- Bachelor’s degree 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.
- Understanding of Reliability Centered Maintenance (RCM) and/or Total Productive Maintenance (TPM) is preferred.
- Knowledge of laboratory and pharmaceutical process support equipment, including Cleaning In Place (CIP), Sterilization In Place (SIP), Autoclaves, and Glass Washers.

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

- Understanding of predictive technologies and their implementation (e.g., vibration analysis, thermal imaging).
- Membership in relevant professional or technical organizations is a plus.
- Basic knowledge of project management principles.
- Develop and oversee Corrective and Preventive Actions (CAPAs) and support change controls.
- Assess and support deviations and Good Manufacturing Practice (GMP) investigations.
- Identify continuous improvement opportunities.

Additional Considerations:
- May require the use of personal protective equipment (PPE) and clean room garments on a daily basis.
- Compliance with specific personal grooming standards while in the manufacturing environment.
- Strong communication skills, both verbal and written, are essential.
- Ability to thrive in a fast-paced environment and manage multiple tasks concurrently.
- Willingness to travel and work across various facilities.
- Potential exposure to various environmental conditions and substances, necessitating adherence to safety protocols.

About Takeda:

At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs.

Takeda is a patient-centric organization that inspires and empowers its employees to grow through impactful work.

Recognized as a Global Top Employer, Takeda offers dynamic career opportunities, fosters innovation, and strives for excellence in all endeavors.

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