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

Job Description:

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Job Description

The Engineer I will provide operational support to process equipment and systems at the Takeda Alewife manufacturing facility.  The position requires experience in GMP production with a primary focus on the process equipment and systems used in the manufacturing of commercial and clinical biologics (vial thaw / cell expansion, roller bottle, various filtration operations, chromatography, CIP / COP systems, and autoclaves).  The Engineer I will also provide supplemental support to the GMP/clean utilities (WFI, purified water, clean steam, compressed air, HVAC, and environmental chambers) as needed. 

The 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 maintain regulatory compliance.

The candidate will serve as the primary contact to Facility Operations, end user organizations (Manufacturing), and external engineering / 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. Candidate will be asked to develop solutions to a variety of limited scope and complex problems and follow standard practices and procedures to analyze solutions. 

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

Education and Experience Requirements

•Required education: Bachelor’s degree in Chemical or Mechanical Engineering.

•Minimum of 0-2 years’ experience in a cGMP Engineering environment.

Key Skills, Abilities, and Competencies

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 is a plus.

Complexity and Problem Solving

•Work with cross-functional groups in developing requirements and recommendations for highly complex system/facility modifications.

•Works on problems of limited scope.  

•Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.  

•Basic level use and/or application of basic principles, theories, and concepts.

•Basic knowledge of industry practices and standards.

•Work is closely supervised. Follows specific, detailed instructions.

•Contributions are usually limited to task-related activities.

This job posting excludes CO applications.

Locations

Worker Type

Worker Sub-Type

Time Type

Full time