Process Engineer III, Global Engineering
Job Title:
Process Engineer IIILocation/Division Specific InformationThermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) 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.The VVS Global Engineering team is passionate about contributing deep process engineering expertise to support our growing business; whether in the design of our next generation equipment platforms, applying innovative strategies and technologies to drive continuous improvement, or providing top-tier engineering support to our operating sites.Location:
This role is based in Massachusetts, either in our Cambridge, Lexington, or Plainville sites, but time may be spent at all VVS facilities including up to 10% travel to the Alachua, FL facility or other locations.How will you make an impact?The Process Engineer III position will be a member of the Viral Vector Services Global Engineering team. They will be responsible for effectively executing global engineering projects including capital equipment purchases, process improvement projects, feasibility & concept studies and supporting facility master plans and buildouts. They may serve as the overall project manager or project technical lead for smaller projects, providing periodic project updates to management. The role requires the ability to manage multiple technical projects at the same time.What will you do?Provide technical leadership, guidance, and support to the operations teams at each VVS site as needed and will partner with the various functions to develop technical roadmaps, capital investment strategies and will lead/participate in strategic design projects.Responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program at VVS for the creation of technical engineering standards.Create and maintain relationships with other VVS sites to develop and promote engineering best practices and ensure compliance with VVS SOP's, safe work practices, and cGMP regulations.Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and Global and Site Engineering teams to complete all responsibilities.How will you get here?Bachelor's degree in Chemical, Electrical or Mechanical Engineering or related engineering or technical field - required.Minimum of 5 years of experience in the biotech engineering/manufacturing environment.Experience with process equipment, utilities, and automation projects and/or supporting these areas in an operating biomanufacturing facility.Experience in an FDA regulated environment.Experience with cGMP unit operation and process equipment 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.Proficient in working with automated systems in a regulated environmentUnderstanding 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.Experience managing projects that must be delivered on schedule and within budgetKnowledge, Skills, AbilitiesWorking knowledge of cGMP standards and practices, along with applicable regulatory requirements (FDA and EMA).Strong technical documentation review and revision experienceAdvanced interpersonal and communications skills; written and oralAbility to work effectively with both local and remote cross-functional teamsSkilled in project management tasks, such as controlling costs against budgets, meeting timelines, resource planning, and presenting project updates.Strong ability to work independentlyComfortable supporting multiple concurrent issuesAt Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Process Engineer IIILocation/Division Specific InformationThermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) 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.The VVS Global Engineering team is passionate about contributing deep process engineering expertise to support our growing business; whether in the design of our next generation equipment platforms, applying innovative strategies and technologies to drive continuous improvement, or providing top-tier engineering support to our operating sites.Location:
This role is based in Massachusetts, either in our Cambridge, Lexington, or Plainville sites, but time may be spent at all VVS facilities including up to 10% travel to the Alachua, FL facility or other locations.How will you make an impact?The Process Engineer III position will be a member of the Viral Vector Services Global Engineering team. They will be responsible for effectively executing global engineering projects including capital equipment purchases, process improvement projects, feasibility & concept studies and supporting facility master plans and buildouts. They may serve as the overall project manager or project technical lead for smaller projects, providing periodic project updates to management. The role requires the ability to manage multiple technical projects at the same time.What will you do?Provide technical leadership, guidance, and support to the operations teams at each VVS site as needed and will partner with the various functions to develop technical roadmaps, capital investment strategies and will lead/participate in strategic design projects.Responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program at VVS for the creation of technical engineering standards.Create and maintain relationships with other VVS sites to develop and promote engineering best practices and ensure compliance with VVS SOP's, safe work practices, and cGMP regulations.Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and Global and Site Engineering teams to complete all responsibilities.How will you get here?Bachelor's degree in Chemical, Electrical or Mechanical Engineering or related engineering or technical field - required.Minimum of 5 years of experience in the biotech engineering/manufacturing environment.Experience with process equipment, utilities, and automation projects and/or supporting these areas in an operating biomanufacturing facility.Experience in an FDA regulated environment.Experience with cGMP unit operation and process equipment 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.Proficient in working with automated systems in a regulated environmentUnderstanding 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.Experience managing projects that must be delivered on schedule and within budgetKnowledge, Skills, AbilitiesWorking knowledge of cGMP standards and practices, along with applicable regulatory requirements (FDA and EMA).Strong technical documentation review and revision experienceAdvanced interpersonal and communications skills; written and oralAbility to work effectively with both local and remote cross-functional teamsSkilled in project management tasks, such as controlling costs against budgets, meeting timelines, resource planning, and presenting project updates.Strong ability to work independentlyComfortable supporting multiple concurrent issuesAt Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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