Senior GMP Maintenance & Utilities Technician

Takeda

Lexington (MA)

On-site

USD 43,000 - 66,000

Full time

21 hours ago
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Job summary

Takeda in Lexington, MA seeks a Senior Maintenance and Utilities Technician to ensure safe, compliant operation of GMP-critical equipment and utility systems. You will lead advanced maintenance, troubleshoot, monitor performance, and triage non-routine events to protect product supply and quality.

This on-site role requires collaborating with Manufacturing, Engineering, Quality, Validation, and contractors, documenting actions in CMMS, and guiding peers to high workmanship.

Qualifications

  • High school diploma or equivalent with 4–8 years of relevant experience, or technical certification or associate degree in a related field with at least 3 years.
  • Experience maintaining, operating, and troubleshooting GMP process equipment and utility systems.
  • Proficiency with CMMS and documentation practices.
  • Strong understanding of cGMP, regulatory compliance, and audit readiness.
  • Ability to work rotating shifts and lift up to 50 pounds.

Responsibilities

  • Respond to alarms and non-routine events by assessing priorities and documenting actions.
  • Serve as primary operational contact during shifts, triaging issues and coordinating support.
  • Monitor and own process equipment and utility systems to maintain readiness.
  • Execute maintenance and reliability activities per GMP safety and procedures.
  • Maintain accurate documentation, including logs, work orders, and calibration records.
  • Collaborate with Manufacturing, Engineering, Quality, Validation, and contractors to improve reliability.
  • Provide technical leadership and knowledge transfer to peers and contractors.
  • Identify reliability and continuous improvement opportunities using performance data.
  • Support maintenance and troubleshooting of GMP process equipment and critical utilities (WFI, RO, autoclaves, etc.).
  • Support inspection/audit readiness with CMMS and site procedures.

Skills

CMMS experience
WFI/RO/autoclaves knowledge
cGMP compliance
Troubleshooting
Documentation

Education

High school diploma or equivalent
Technical certification / associate degree
Military technical training

Tools

CMMS
P&IDs interpretation

Job description

Takeda in Lexington, MA seeks a Senior Maintenance and Utilities Technician to ensure safe, compliant operation of GMP-critical equipment and utility systems. You will lead advanced maintenance, troubleshoot, monitor performance, and triage non-routine events to protect product supply and quality.

This on-site role requires collaborating with Manufacturing, Engineering, Quality, Validation, and contractors, documenting actions in CMMS, and guiding peers to high workmanship.

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