GMP Tech Transfer Engineer: Process Validation & Scale-Up

INCOG BioPharma Services; Fishers (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Technical Transfer Engineer to support tech transfer, process validation, GMP floor activities, and continued process verification for clinical and commercial programs.

You will autonomously scale up and transfer processes to full-scale manufacturing, select appropriate GMP equipment, author critical documents, monitor data, and drive root-cause investigations with cross-functional teams.

Qualifications

• GMP experience in pharmaceutical manufacturing required.
• Experience in technical transfer for pharma or related industry.
• Ability to work with cross-functional teams and communicate with customers.

Responsibilities

• Scale up and transfer processes to full-scale manufacturing based on data.
• Select appropriate GMP equipment and develop technical docs (Tech Transfer Plan, Gap Assessments, PFD, Summary Reports, FMEA).
• Represent TSMS in project teams and communicate with customers as SME for manufacturing processes.
• Author GMP documentation (Master Batch Records, BOM, Processing Forms).
• Monitor process data, identify trends and propose actions.

Skills

GMP experience

Technical transfer

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering preferred

Job description

INCOG BioPharma Services in Fishers, IN is seeking a Technical Transfer Engineer to support tech transfer, process validation, GMP floor activities, and continued process verification for clinical and commercial programs.

You will autonomously scale up and transfer processes to full-scale manufacturing, select appropriate GMP equipment, author critical documents, monitor data, and drive root-cause investigations with cross-functional teams.