Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
The Staff Engineer will report directly to the Process Engineering Manager. They are responsible for supporting equipment operability and readiness for ongoing manufacturing operations and new product technology transfers. They will provide technical expertise and mentorship to the engineering team and serve as a technical leader on projects with global engineering and site leadership.
What will you do?
- Mentor and provide guidance to a team of process engineers engaged in tech transfers of new products into the manufacturing facility and provides continued support throughout manufacturing campaigns, as well as serve as a technical lead on the same projects.
- Oversee equipment specification of manufacturing and analytical equipment and identifies opportunities to improve robustness, reliability, and other aspects of operational performance.
- Work with the Process Engineering Manager and Global Engineering team to plan and manage operational budgets and capital investments.
- Network with other Thermo Fisher sites to develop and promote engineering best practices and ensures compliance with Thermo Fisher SOPs, safe work practices, and cGMP regulations.
- Collaborate with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
- B.S. degree in chemical engineering, mechanical engineering, biochemical/biomedical engineering, electrical engineering, automation engineering, or related engineering field.
- Minimum of 10 year of work in biotechnology, pharmaceuticals or related field.
- Experience with process equipment and operations such as bioreactors, filtration systems, chromatography skids, autoclaves, and filling equipment etc. is required.
- Strong exposure to general cGMP standards and industry engineering best practices and be capable of leveraging and generating user requirements, design, and procurement activities for manufacturing process equipment design and procurement.
- Experience supporting biologic manufacturing processes within an FDA/EMA regulated environment.
Knowledge, Skills, Abilities
- An ability and desire to help with the development of younger engineers on the team.
- Strong interpersonal and communications skills; written and oral
- Experience with Project Management.
- Strong ability to manage work in accordance with site quality systems CAPAs, Deviations, Change Controls.
- Technical documentation review and revision experience.
- Ability to work with both on-site and remote based staff.
- Ability to work independently and with cross-functional teams.
- Comfortable supporting concurrent issues and working in an exciting, fast-paced environment.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.