MSAT Engineer
Description
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.
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.
Essential Job Functions:
• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram and Process FMEA.
• Represents MSAT in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes.
• Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitor Process Data, identify trends and propose actions as necessary.
• Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
• Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing.
• Able to assess impact of changes to the product, process, equipment, procedures and/or materials.
• Other responsibilities as required.
• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram and Process FMEA.
• Represents MSAT in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes.
• Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitor Process Data, identify trends and propose actions as necessary.
• Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
• Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing.
• Able to assess impact of changes to the product, process, equipment, procedures and/or materials.
• Other responsibilities as required.
Special Job Requirements:
• Bachelor’s degree in science or engineering.
• Master’s degree in science or engineering preferred.
• 0-2 years GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.
• Bachelor’s degree in science or engineering.
• Master’s degree in science or engineering preferred.
• 0-2 years GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
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. We will not tolerate discrimination or harassment based on any of these characteristics.
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