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Plant Engineer II

Newton Center, Massachusetts
Remote Working
Remote Working
Job Type
3 Sep 2022

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Job Description

About the role:

Manage the performance and monitoring of plant utility systems. Your primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Process Gasses, and HVAC systems). A familiarity with non-GMP/plant utilities and operations (Plant Steam, Chilled Water, Electrical and Waste Treatment) is desirable.

Responsibilities include troubleshooting, determining root cause of problems and providing optimization strategies for utility systems within a multi-product, FDA regulated GMP facility. Candidate will be the primary liaison between manufacturing and facilities clients and external engineering contractors and vendors for utility systems. All system improvements will be made together with manufacturing, facilities, validation, quality assurance, and regulatory. You will report to the Plant Engineering Manager.

How you will contribute:
  • Be a subject matter expert to support assigned work orders and close out Quality Systems as applicable
  • On call support 24/7
  • Communicate project requirements to vendors to obtain proposals for equipment and system changes
  • Develop engineering tests, FATs, SATs and commissioning test plans
  • Train operations staff on new/ revised operating procedures
  • Pre/Post approve validation protocols
  • Support develop engineering project documentation
  • Accountable for all phases of the Change Control process for owned changes
  • Manage closure of plant equipment and system related CAPAs
  • Use project management skills to schedule, track progress, and make adjustments
  • Use appropriate business / quality systems such as Trackwise, CMMS, EDC.
  • Knowledge of how small projects tie into other sites
Minimum Requirements/Qualifications:
  • Required education: Bachelor's degree in mechanical or Chemical Engineering
  • Minimum 3 years' experience with process or plan utility systems in a regulated environment
  • You will follow domestic and international GMP regulations
  • Proficiency with Microsoft products;,TrackWise experience.
What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings, paid time off for vacation, sick leave, and volunteering
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional development opportunities
  • Tuition reimbursement
Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

  • 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 and work in a cold, wet environment.
  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.

This position is classified as "hybrid" following Takeda's Hybrid and Remote Work policy. Schedule will be defined in office with manager.

The CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.


USA - MA - Lexington - BIO OPS

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  • Job Reference: 703157678-2
  • Date Posted: 3 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Newton Center, Massachusetts
  • Remote Working: Some remote working possible
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent