Cambridge, MA, United States
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 Project Engineer role supports operations through implementation of engineering projects. The role provides a project management resource to operations customer to ensure that equipment, facilities and automation are designed and operating to meet the requirements for gene-theory (viral vector) manufacturing sites in Massachusetts (Lexington and Cambridge). The Project Engineer will manage daily control over large projects or a number of smaller capital projects which must be delivered to time and within budget.Essential Job Functions:Manage and provide technical leadership for capital projects. Ensures project timelines are met as well as manages financial spending related to the project. Communicates status, timelines and challenges to senior management. (80%)Assist in capital investment planning and management (10%)Engineering standards development and administration (10%) POSITION REQUIREMENTS:Manage Capital projects from Planning, Design, Execution and Close-Out stages of the projectComply with all Quality and Safety regulations, local and corporate policies and procedures.Works closely with key stakeholder to determine and ensure project scope and scheduling.Works closely with key stakeholder to develop a Project Execution Plan, User Requirements, Functional Specifications, Design SpecificationsWorks with CQV team to produce the required commissioning and validation documents: IQ, OQ and PQ’s.Provides periodic project updates to managementManage and coordinate engineering contractors to meet project objectivesManage construction activitiesManage startup and commissioning activitiesLeads equipment procurement activitiesIn addition to executing engineering projects, the Project Engineer role may also provide technical support to ongoing plant operations if neededHelp develop Good Engineering Practices (GEP) program to ensure consistent execution of delivery of projects10% domestic and international travel may be requiredEDUCATION AND QUALIFICATIONS:Minimum of 8 years of experience in the biotech engineering/manufacturing environmentMinimum 5 years of experience in the management and coordination of engineering and construction projectsBachelor of Science degree in Chemical, Electrical or Mechanical Engineering or related engineering fieldExperience with executing construction, equipment, utilities and automation projectsWorking Knowledge of cGMP, OSHA, NEC and EPA regulations.Experience in an FDA regulated environmentPHYSICAL DEMANDS/FACTORS:While performing the duties of this job, the employee:Needs Ability to aseptically gown and/or sterile gown as neededAbility to work within environmental clean roomsAbility to work on construction sitesAbility to function in a dynamic environment and balance multiple priorities simultaneouslyStrong writing and documentation skillsExceptional verbal communication and presentation skills. 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.