Senior Maintenance and Utilities Technician (Days)

Takeda; Lexington (MA); Presencial; USD 43.000 - 66.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CMMS experience

WFI/RO/autoclaves knowledge

cGMP compliance

Troubleshooting

Documentation

Educación

High school diploma or equivalent

Technical certification / associate degree

Military technical training

Herramientas

CMMS

P&IDs interpretation

Descripción del empleo

Job Description

About The Role

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.

How you will contribute

• 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.

What you bring to Takeda

• High school diploma or equivalent with 4–8 years of relevant experience, or technical certification, associate degree, military technical training, or equivalent technical education in a related field with at least 3 years of relevant experience.
• Demonstrated competency in maintaining, operating, and troubleshooting process equipment and critical utility systems, including WFI, RO, autoclaves, clean utilities, chromatography systems, ultrafiltration skids, and other GMP manufacturing support systems, as applicable.
• Advanced troubleshooting and diagnostic skills for process and utility systems, with the ability to interpret technical documentation, including piping and instrumentation diagrams (P&IDs), equipment drawings, and technical manuals.
• Strong understanding of cGMP requirements, maintenance documentation, regulatory compliance, and audit readiness, with demonstrated ownership of equipment performance, operational readiness, and work quality.
• Proficiency in preventive and corrective maintenance execution and computerized maintenance management systems (CMMS), along with the ability to use digital tools and electronic business systems supporting procurement, safety, maintenance, and quality management.
• Ability to work independently with minimal supervision, manage competing priorities in a dynamic environment, and collaborate effectively with Manufacturing, Engineering, Quality, contractors, and other stakeholders.
• Strong commitment to safety, compliance, and continuous improvement, with the ability to guide peers and contractors. Ability to obtain and maintain an Industrial 1I or higher Massachusetts Wastewater Operator license as required by site needs, and to perform or support confined space entry activities when applicable and authorized. Ability to meet physical requirements, including wearing required PPE, gowning for pharmaceutical manufacturing areas, lifting, pushing, or pulling up to 50 pounds, standing for extended periods, climbing ladders and working from platforms, bending or stooping to troubleshoot equipment, handling approved site chemicals, and traveling or working across Massachusetts Bio Ops facilities as required.

Important Considerations

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

This is an on-site role in Lexington, Massachusetts, required to support GMP manufacturing operations, plant readiness, and shift coverage needs.

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range

$30.43 - $47.81

Benefits

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.