GMP Tech Transfer Engineer – Process Validation

incog; Fishers (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks a Technical Transfer Engineer to scale up and transfer manufacturing processes into full-scale production, ensuring cGMP compliance.

You will author critical GMP documentation, support Process Validation and Continued Process Verification, and collaborate with cross-functional teams to implement new technologies and optimize product quality.

Qualifications

• 1-3 years of GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.
• Bachelor's degree in Science or Engineering; Master’s degree preferred.

Responsibilities

• Scale up and transfer process into full-scale manufacturing based on data.
• Select equipment and single-use components for GMP manufacturing and develop tech docs.
• Represent TSMS in project teams and communicate with customers; act as SME for processes.
• Author GMP manufacturing documentation including Master Batch Records, BOMs and Processing Forms.
• Monitor process data; identify trends and propose actions.

Skills

GMP experience

Technical Transfer

Cross-functional communication

Education

Bachelor's degree in Science or Engineering

Master's degree preferred

Job description

INCOG BioPharma Services in Fishers, IN seeks a Technical Transfer Engineer to scale up and transfer manufacturing processes into full-scale production, ensuring cGMP compliance.

You will author critical GMP documentation, support Process Validation and Continued Process Verification, and collaborate with cross-functional teams to implement new technologies and optimize product quality.