Process Engineer III, Manufacturing Sciences and Technologies

Thermo 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. 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.

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.

How will you make an impact?

The Process Engineer III will be responsible for implementation of robust, scalable and efficient manufacturing processes through leading technology transfer, Process Validation, late stage clinical and commercial manufacturing technical support activities. The individual will provide technical expertise and leadership and requires close collaboration with throughout the organization.

What will you do?

• Write and execute process validation protocols and related documentation for viral vector manufacturing processes from cell culture through final fill
• Compile and analyze results of process validation activities related to Stage 2 (Process Performance Qualification) and Stage 3 (Continued Process Verification)
• Monitor and trend process parameters and performance and perform statistical analyses
• Manage process validation studies and projects through to closure per timelines
• Draft and maintain process control strategy documents throughout the lifecycle of a program
• Author and maintain process risk assessment documents
• Perform root cause analyses, product and process impact assessments and identify corrective and preventative actions for process deviations
• Manage investigations to address validation discrepancies
• Represent process validation during site tech transfer and GMP activities and participate on cross functional teams to facilitate technology transfer and project success
• Identify opportunities to improve systems and practices
• Keep current on regulatory and quality requirements and follow Environment, Health and Safety policies

Education

• A degree in biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry, or closely related field. Advanced degree preferred.
• B.S. with 8+ years, Master's degree with 6+ years' experience, or PhD with 3+ years' experience.

Knowledge, Skills, Abilities

• Technical expertise in biopharmaceutical manufacturing and/or process development.
• Experience with a variety of at-scale filtration and column purification methods including TFF, Depth and viral filtration, affinity, ion exchange and size exclusion chromatography as well as applicable analytical methods for process characterization.
• Experience in late stage/commercial technology transfer, process characterization and process validation.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.

• Knowledge of cell and gene therapy vector production highly desirable.
• Ability to work both independently and as part of a team.
• Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
• Project management skills desirable
• Laboratory skills and the ability to be hands-on.
• Ability to speak effectively before groups of customers.
• Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.
• Strong interpersonal and communication skills, verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic 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.