Senior GMP Equipment & Utilities Specialist

Takeda Pharmaceutical Co.

Lexington (MA)

On-site

USD 4,192,000 - 6,586,000

Full time

3 days ago
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Job summary

Takeda in Lexington, MA is seeking a Senior Maintenance and Utilities Technician to ensure safe, compliant operation of critical process equipment and utility systems in GMP manufacturing. You will perform advanced maintenance, troubleshooting, and non-routine triage to maximize equipment reliability and plant readiness on a rotating 6:00 AM–6:30 PM schedule.

You will collaborate with Manufacturing, Engineering, Quality, Validation, and contractors, drive continuous improvement, and ensure

Qualifications

  • High school diploma or equivalent with relevant technical experience in GMP environments.
  • Experience maintaining, operating, and troubleshooting process equipment and utility systems (WFI, RO, autoclaves, clean utilities).
  • Strong diagnostic skills; ability to read P&IDs and technical manuals.
  • Solid understanding of cGMP requirements and audit readiness.
  • Proficient with CMMS and documenting work thoroughly.

Responsibilities

  • Respond to alarms and triage non-routine events to minimize disruptions.
  • Serve as primary shift contact; triage issues and coordinate support to manufacturing operations.
  • Monitor, maintain, and own process equipment and utility systems for ongoing readiness.
  • Perform preventive and corrective maintenance per GMP procedures and safety rules.
  • Maintain accurate work orders, logbooks, calibration records, and GMP documents.
  • Collaborate with Manufacturing, Engineering, Quality, and vendors to improve reliability.
  • Provide technical leadership and knowledge transfer to peers and contractors.
  • Identify reliability improvements by analyzing equipment performance data.

Skills

Maintenance experience
CMMS proficiency
cGMP compliance
Technical diagnostic skills
Documentation

Education

High school diploma or equivalent

Tools

CMMS
P&IDs

Job description

Takeda in Lexington, MA is seeking a Senior Maintenance and Utilities Technician to ensure safe, compliant operation of critical process equipment and utility systems in GMP manufacturing. You will perform advanced maintenance, troubleshooting, and non-routine triage to maximize equipment reliability and plant readiness on a rotating 6:00 AM–6:30 PM schedule.

You will collaborate with Manufacturing, Engineering, Quality, Validation, and contractors, drive continuous improvement, and ensure

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