Cambridge, MA, United States
Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.Summary:The Lead Process / Equipment Engineer is a member of the Global Engineering Asset Management Team with primary responsibility for Brammer Bio’s equipment assets in the Cambridge site encompassing GMP Manufacturing, Process Development, and Quality Control. The Global Engineering Asset Management function provides technical oversight of capital expenditures and maximizes asset utilization across Brammer’s network of facilities. In this role, the Lead Process / Equipment Engineer works with the Cambridge Facilities and Engineering team and other site teams to develop and maintain a detailed understanding of equipment capability, status and usage plans, performance and reliability.Essential Job Functions:Develop and manage site asset lists to support portfolio review, usage plans, and equipment lifecycle managementProvide technical review of capital expenditures and specification of equipmentPerform equipment fit and room layout assessments including conceptual designs and feasibility studiesTrack equipment and single use component issues and failures and work with vendors to resolveReview site documentation and equipment to ensure alignment with Global Engineering and Good Engineering Practice standards. Education and Qualifications:Minimum of 8 years of experience in the biotech engineering/manufacturing environment required for Senior level position - individuals with less experience will be considered for positions commensurate with experience.Significant experience with cGMP process equipment and operations such as cell culture, bioreactors, filtration, chromatography, autoclaves, incubators, etc.Bachelor of Science degree in Chemical, Electrical or Mechanical Engineering or related engineering fieldExperience with single-use technologies and systems preferredExperience with database management, engineering software such as Bluebeam Revu and modeling, simulation, and scheduling software such as Intelligen SuperPro and SchedulePro is desirableWorking Knowledge of cGMP standards and industry engineering best practices in an FDA regulated environmentTechnical documentation review and revision experience. Capable of leading user requirements definition, design, and procurement activities for manufacturing process equipmentStrong communication and information management skills requiredAbility to work with both hands-on and remote based staffAbility to work independently and with cross-functional teamsComfortable supporting concurrent issues and working in an exciting, fast-paced 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 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.