Senior Technical Transfer Engineer
INCOG BioPharma Services · Fishers, Indiana · Posted May 26, 2026
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TSMS – Senior Technical Transfer Engineer
The Technical Services and Manufacturing Sciences ( TSMS ) Senior Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.
Essential Job Functions:
Lead multiple complex technical transfer projects simultaneously from development through commercial manufacturing
Develop and implement advanced process optimization strategies and statistical process control methodologies
Serve as technical lead on cross-functional project teams coordinating with Quality, Manufacturing, and client teams
Provide technical guidance and mentorship to Entry Level engineers and review their work
Author complex technical documents including Process Validation Master Plans, Comparability Protocols, and tech transfer reports
Serve as primary technical contact for clients and present technical recommendations in client meetings
Lead root cause investigations for complex manufacturing issues and assist in develop ing comprehensive CAPAs
Evaluate and implement new manufacturing technologies, equipment platforms, and process improvements
Ensure all activities comply with cGMP regulations, company SOPs, and client requirements
Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
Manage t imelines and appropriately prioritize critical path tasks to meet deadlines
Identify continuous improvement opportunities and lead implementation of those improvements
Other responsibilities as required
Special Job Requirements:
Bachelor's degree in Science or Engineering required
Master's degree in Science or Engineering preferred
Minimum 3 years of GMP experience required
Minimum 2 years of Technical Transfer experience in pharmaceutical/biotech industry
Demonstrated leadership experience and mentoring capabilities
Strong project management skills with ability to manage multiple complex projects simultaneously
Experience with client-facing technical presentations
Proficiency in statistical analysis software and process validation methodologies