Senior MSAT Engineer

Company: INCOG BioPharma Services
Location: Fishers
Posted on: September 21, 2023

Job Description:

The Senior Manufacturing Science and Technology (MSAT) Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.This position holds the responsibility of delivering substantial technical guidance and supervision throughout the production process. The primary objective is to establish production processes that are not only robust and reliable but also capable of consistently delivering high-quality products. This entails overseeing the various stages of production, identifying potential areas for improvement, and implementing measures to enhance the overall efficiency and effectiveness of the production operations.Job responsibilities:

• The MSAT Engineer is responsible for scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client
• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports 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 requiredRequirements:
  • Bachelor's degree in science or engineering
  • Master's degree in science or engineering preferred
  • 3+ years GMP experience required
  • Experience in Technical Transfer for pharmaceutical or related industryAdditional 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 working for a high growth company and believe you have the intuition for a enhancing the 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.By submitting your resume and details, you are declaring that the information is correct and accurate.
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Keywords: INCOG BioPharma Services, Fishers , Senior MSAT Engineer, Engineering , Fishers, Indiana