Thermo Fisher Scientific Engineer III (Sr Engineer) Process Engineering (Cambridge) in Cambridge, Massachusetts
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.
Responsible for the support of clinical and commercial drug manufacturing in the new Manufacturing facility located at the Cambridge, MA campus. Scope includes designing, specifying, and supporting utility equipment such as Bioreactors, Chromatography Systems, TFF Systems, and Filling equipment in our newly built manufacturing facility. Individual will be part of an experienced team of process and automation engineers working closely with groups such as manufacturing, quality assurance, quality control and validation. This scope will also include identifying and driving continuous improvements to processes and equipment, aligning/coordinating capabilities across sites within the company, and ensuring that the capabilities of the Cambridge site meets all regulatory requirements necessary for commercial manufacturing. This person will be responsible for acting as senior technical lead in group, providing guidance to other group members, and driving improvements. Experience and Skills Experience with cGMP equipment such as Bioreactor, Chrom Systems, TFF Systems etc.. Extensive Experience with equipment design Detailed understanding of cGMP standards and practices Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing equipment Minimum of 15 years of experience in the biotech engineering/manufacturing environment.
The incumbent is required to have minimum a Bachelor of Science degree in Automation, Electrical, Chemical or Mechanical Engineering 10 Years’ experience in cGMP environment with audit experience. Key skills/desired experience: Knowledge of testing and associated equipment protocols and requirements and applicable equipment Strong interpersonal and communications skills; written and oral. Basic understanding of applicable regulatory requirements. Technical documentation review and revision experience. Working with both hands-on and remote based staff Ability to work independently Comfortable supporting concurrent issues.
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 https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility 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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