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USA - MA - Lexington - BIO OPS
Source: Takeda careers · View original posting
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Job Description
As a Senior Maintenance and Utilities Technician, you will work within the Site Engineering organization to ensure the safe, compliant, and reliable operation of critical process equipment, manufacturing systems, and utility infrastructure supporting Good Manufacturing Practice (GMP) manufacturing operations.
You will perform advanced maintenance, troubleshooting, operational monitoring, alarm response, and non-routine event triage to maintain plant readiness, maximize equipment reliability, and minimize risks to product supply, quality, safety, and regulatory compliance.
Working closely with Manufacturing, Engineering, Quality, Validation, and external service providers, you will take ownership of equipment performance, support operational continuity, and drive continuous improvement while maintaining high standards of safety, documentation, and compliance.
This position works 6:00AM - 6:30PM on a rotating schedule .
Respond to alarms, abnormal conditions, and non-routine equipment or utility events by assessing priorities, communicating operational impacts, and ensuring timely escalation, coordination, and documentation.
Serve as the primary operational contact during assigned shifts by triaging issues, screening calls, prioritizing responses, determining resource requirements, and coordinating support to minimize disruptions to manufacturing operations.
Monitor, maintain, and take ownership of process equipment and utility systems to ensure continuous plant readiness, proactively identifying and addressing performance deviations.
Execute maintenance and reliability activities in accordance with site safety requirements, current GMP (cGMP) standards, and regulatory expectations, including hazard assessments, proper personal protective equipment (PPE) use, and adherence to approved procedures.
Maintain accurate, complete, and timely documentation, including work orders, logbooks, maintenance and calibration records, alarm and event reports, and other GMP records required to support compliant, audit-ready operations.
Partner with Manufacturing, Engineering, Quality, Validation, contractors, vendors, and equipment manufacturers to troubleshoot issues, improve equipment reliability, and ensure work is completed safely, compliantly, and right-first-time.
Provide technical leadership, guidance, and knowledge transfer to peers and contractors, promoting accountability, collaboration, and high standards of workmanship.
Identify and support reliability and continuous improvement initiatives by analyzing equipment performance data and operational trends to strengthen maintenance strategies, improve equipment reliability, and reduce operational risk.
Support the maintenance, operation, and troubleshooting of process equipment and critical utility systems, including water for injection (WFI), reverse osmosis (RO), autoclaves, clean utilities, chromatography systems, ultrafiltration skids, and other GMP manufacturing support systems, as applicable.
Support inspection and audit readiness by maintaining compliant maintenance practices and documentation, using computerized maintenance management systems (CMMS), and following site procedures for safety, confined space entry, and other assigned activities.
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