Tech Transfer Process Engineer

Seeking an experienced Tech Transfer Process Engineer to support New Product Introduction (NPI) and technical transfer activities within a sterile aseptic fill-finish manufacturing environment. The role involves leading process transfers from incoming clients, developing transfer strategies, authoring technical documentation, conducting risk assessments, and supporting process validation activities.

• Lead NPI and technical transfer activities for incoming client products.
• Develop and execute transfer plans, process control strategies, and validation activities.
• Perform risk assessments and support process development efforts.
• Author protocols, reports, and technical documentation.
• Manage change controls, deviations, and study closeout reports.
• Collaborate directly with clients and cross-functional teams throughout the transfer process.
• Provide hands-on support on the manufacturing floor during process execution and validation.

• 8 10 years of pharmaceutical manufacturing experience.
• Strong experience in NPI and technical transfer projects.
• Hands-on experience in sterile aseptic fill-finish manufacturing environments.
• Experience supporting manufacturing operations and working directly on production lines.
• Ability to work in a fast-paced CDMO environment.
• Experience with change controls, deviations, protocol writing, and technical reporting.

• Bachelor's degree in Chemical Engineering or a related discipline (preferred, not required).
• Strong client-facing communication and stakeholder management skills.
• Highly organized, confident, and hands-on approach to problem-solving.

• NPI Technical Transfer experience.
• Aseptic sterile fill-finish manufacturing experience.
• Pharmaceutical/CDMO background.
• Willingness to work hands-on in a manufacturing environment.
• Strong client-facing communication skills.