Alewife Sr. Engineer I at Shire Human Genetic Therapies, Inc. in Cambridge, Massachusetts

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Engineer I in our Cambridge, MA at our Alewife site.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

The Senior Engineer I will provide operational support to equipment and systems in the manufacturing of commercial products at Takeda Alewife (Cambridge) MA manufacturing site as well as ancillary support (<10%) of the North Reading and Belmont GMP warehouses.  The Engineering function covers all equipment and systems related to the following with a focus on manufacturing process systems:

• Process Systems
  
  
  • Vial Thaw / Cell Expansion
  
  
  • Bioreactor operations
  
  
  • Clarification
  
  
  • Roller bottle operations
  
  
  • Single Use
  
  
  • Ultrafiltration / Diafiltration Systems
  
  
  • Chromatography Systems
  
  
  • Filtration Systems
  
  
  • Viral Filtration/Inactivation Systems
  
  
  • Media/Buffer solution preparation
  
  
  • Clean-in-place skids and cycles
  
  
  • Clean-out-of-place washers, glass washers
  
  
  • Steam-in-place cycles
  
  
  • Autoclaves and cycle development
  
  
  • Filter integrity testing
  
  
  • Bench top process analytics and technology
  
  
  
  


• Plant/Utilities Systems
  
  
  • GMP/clean utilities (WFI, Purified Water, Clean Steam and Compressed Air)
  
  
  • HVAC (ISO clean room Class 8/7)
  
  
  • Environmental Chambers/Transport (cold/warm rooms and temperature controlled vehicles).
  
  
  • Indirect/No Impact plant utilities (Plant Steam, Chilled Water, HVAC, electrical and condensate systems)
  
  
  
  


• Good engineering practices (procedures and standards for engineering lifecycle covering requirements, specification & design, verification, acceptance & release)

The Senior Engineer I will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems and providing optimization strategies for process equipment within a multi-product, FDA regulated, cGMP facility.  The candidate will ensure that a large number of highly complex pieces of process equipment and systems remain within their validated state and regulatory compliance.

Candidate will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives. Candidate will be a prime contact to Manufacturing and Facilities and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities.   All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Sciences, Quality Assurance, Validation and Regulatory.

Must be able to work in a fast-paced multi-disciplinary environment.

Operational support

• Troubleshooting support for complex process and plant equipment problems as elevated by Eng I /II


• Serves as subject matter expert for process systems within assigned area. 


• Serves as subject matter expert for Quality Systems and Regulatory filings


• Interface with manufacturing management to highlight operational project priorities and communicate with priorities with junior engineers


• On call support 24/7, expected to carry smart phone device for on-call support as required

Small Project Support

• Accountable for all phases of the Change Control process for owned changes


• Owns and ensures timely closure of equipment related CAPAs and Change Controls


• Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)


• Use project management skills to schedule, track progress, and make adjustments


• Defines all aspects of project scope


• Uses appropriate business / quality systems such as Trackwise, Veeva, etc.


• Knowledge of how small projects to tie in to other sites


• Provide peer review for all QA and Engineering documentation


• May act as project manager for small process equipment projects

Large Project Support

• Provide project team with engineering design requirements


• Provide budgetary and schedule estimates for the requirements of projects


• Develop and support any feasibility studies or engineering tests required to define project scope.


• Communicate project requirements to vendors to obtain proposals for equipment, Single Use, and piping changes


• Execute JHA/PHA reviews on all new projects/equipment


• Perform EHS management of change and HAZOP documentation as required


• Develop and execute engineering tests, FATs, SATs and commissioning test plans (CTPs)


• Train operations staff on new/revised operating procedures


• Pre/Post approve validation protocols


• Troubleshoot and remediate exceptions found during IQ/OQ/PQ


• Develop engineering project documentation


• May assist project manager with their role on large projects


• Travel is currently limited to vendor visits including FAT’s and external commissioning.

Standards and Templates

• Develop / Improve engineering standard practices that will result in consistent, reproducible documents site-to-site

• Identifies equipment specific best practices and performs gap analysis between Takeda and best practice


• Keep abreast of advancement in new technologies and engineering best practices.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Required education: Bachelors degree in Chemical or Mechanical Engineering; Bachelor’s degree in Bioengineering also acceptable


• Minimum 5-8 years experience in a cGMP Engineering environment


• Minimum 5+ years experience in equipment design and oversight of fabrication


• Effective verbal and written communication skills


• Excellent interpersonal and teamwork skills required


• Adherence to domestic and international GMP regulations


• Ability to multi-task in a dynamic environment with changing priorities


• Proficiency with Microsoft products; ability to learn additional software applications, as the need arises – TrackWise experience a plus

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan


• Tuition reimbursement Company match of charitable contributions


• Health & Wellness programs including onsite flu shots and health screenings


• Generous time off for vacation and the option to purchase additional vacation days


• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

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Location and Salary Information:

This job posting excludes CO applicants.

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Full time