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
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