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Job Details

Staff Manager Engineer Process- Cambridge MA

Location
Cambridge, MA, United States

Posted on
Nov 09,2019

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Job Description

Brammer Bio, part of Thermo Fisher Scientific, is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future. The Staff Engineer, Process will be a member of the Viral Vector Services Global Engineering team.


The Staff Engineer is responsible for providing advanced level expertise to global engineering projects including feasibility & concept studies, capital facility buildouts and equipment purchases, facility master plans, process improvement projects, etc.
He/she may serve as the overall project lead or project technical lead.
The role requires the ability to manage multiple contractors and a portfolio of technical projects at the same time.
The Staff Engineer will provide technical leadership, guidance, and support to the operations teams at each Brammer Bio site as needed and will partner with the various functions to develop technical roadmaps and capital investment strategies.
The Staff Engineer will be responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program at Brammer Bio for the creation of technical engineering standards.
(S)he creates and maintains relationships with other Brammer Bio sites to develop and promote engineering best practices and ensures compliance with Brammer Bio SOP’s, safe work practices, and cGMP regulations.
The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and Global and Site Engineering teams to complete all responsibilities.


The position is based in Cambridge, MA, but time may be spent at other local Brammer Bio facilities and up to 20% travel to the Alachua, FL facility.

-Minimum of 12 years of experience in the biotech engineering/manufacturing environment.

-Bachelor of Science degree in Chemical, Electrical or Mechanical Engineering or related engineering field.

-Experience with executing cGMP facility construction, process equipment, utilities, and automation projects and/or supporting these areas in an operating biomanufacturing facility.

-Working knowledge of cGMP, OSHA, NEC and EPA regulations.

-Experience in an FDA regulated environment.

-Capability to define and set technical direction for cGMP manufacturing processes; cGMP processing equipment; and building and utility systems.

-Extensive experience with cGMP process equipment and operations such as cell culture, bioreactors, filtration, chromatography, autoclaves, incubators, etc., as well as cGMP clean utility systems.

-Experience with single-use technologies is highly desirable.

-Strong understanding of industry standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GXP laboratories.

-Experience with biologics drug substance and/or drug product manufacturing. In depth understanding of general cGMP standards and practices

-Strong understanding of applicable regulatory requirements (FDA and EMA)

-Strong interpersonal and communications skills; written and oral Ability to work effectively with both local and remote teams in a matrix environment.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at **** for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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