INCOG BioPharma Services is hiring: TSMS Engineer, 3rd shift in Fishers

The Manufacturing Science and Technology 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 business to ensure robust and reliable production processes are established. The MSAT Engineer is responsible for scaling up and transferring processes into full scale manufacturing process based on data generated internally or received from the client.

This is a 3rd shift position.

Essential Job Responsibilities:

• Develop technical documentation such as Process FMEA, Process Flow Diagrams, and Tech Transfer Plans
• Select appropriate equipment and single-use components for GMP manufacturing
• Recognized as Subject Matter Expert for manufacturing processes in project teams
• Author GMP manufacturing documentation including Master Batch Records, BOM, and Processing Forms
• Monitor process data, identifying trends and proposing actions
• Lead technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventative actions
• Provide technical guidance and oversight to Operations and Validation group to support process performance qualification and continuous process verification
• Assess the impact of changes to the product, process, equipment, procedures, and/or materials

Special Job Requirements:

• Bachelor’s degree in science or engineering
• 2+ years in Technical Transfer for pharmaceutical or similar industry
• 2+ years GMP experience
• 1+ year in client-facing role
• Master’s degree preferred

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.