||Thermo Fisher Scientific
|| Biotechnology and Pharmaceutical, Engineering, Healthcare, Other, Information Technology, Manufacturing and Production, Purchasing, Quality Control, Research & Development, Medical
Process Engineer II|
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.
Viral Vector Services (VVS), a division 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.
How will you make an impact?
The Process Engineer II is responsible for the design, optimization, and on-going support of manufacturing operations at Thermo Fisher Scientific’s Lexington, MA manufacturing facility. The primary focus of the position will be supporting the manufacturing process equipment in upstream, downstream, and fill/finish processing areas. This will include participating in new technology transfers, leading troubleshooting equipment issues, optimizing unit operations, and contributing cross-functionally to support manufacturing goals. The role will reside in Lexington, MA.
What will you do?
How will you get there?
- Lead process engineering activities during tech transfers of new products into the manufacturing facility and provides continued support throughout manufacturing campaigns.
- Design, specify, and support manufacturing equipment and analytical equipment including implementing modifications to improve operational performance and product quality.
- Ensure compliance with Thermo Fisher Scientific’s SOP’s, safe work practices, Engineering Standards, and cGMP regulations.
- Collaborate with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
Knowledge, Skills, Abilities
- B.S. degree in chemical engineering, mechanical engineering, biochemical/biomedical engineering, electrical engineering, automation engineering, or related engineering field.
- Minimum of 2 years of appropriate experience is required.
- Educational equivalence may be considered.
- Experience with process equipment and operations such as bioreactors, filtration systems, chromatography skids, filling equipment etc. is required.
- 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
- Experience supporting biologic manufacturing processes within an FDA/EMA regulated environment
- Strong interpersonal and communications skills; written and oral
- Technical documentation review and revision experience
- Ability to work with both hands-on 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
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.