MSAT Engineer
3 weeks ago
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.
Candidate 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.
-
MSAT Engineer
7 days ago
Fishers, United States INCOG BioPharma Services Full timeDescription 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...
-
MSAT Engineer
3 weeks ago
Fishers, United States INCOG BioPharma Services Full timeJob 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...
-
MSAT Tech Writer
4 weeks ago
Fishers, United States INCOG BioPharma Services Full timeINCOG Biopharma Services in Indianapolis, IN is hiring an MSAT Tech Writer. This role is crucial for translating complex technical processes and data into clear, accurate, and accessible documentation. The Technical Writer will work closely with the MSAT engineers and other cross-functional teams to create comprehensive documentation that supports tech...
-
MSAT Tech Writer
4 weeks ago
Fishers, United States INCOG BioPharma Services Full timeINCOG Biopharma Services in Indianapolis, IN is hiring an MSAT Tech Writer. This role is crucial for translating complex technical processes and data into clear, accurate, and accessible documentation. The Technical Writer will work closely with the MSAT engineers and other cross-functional teams to create comprehensive documentation that supports tech...
-
Senior MS&T Engineer
4 weeks ago
Fishers, United States INCOG BioPharma Services Full timeJob Functions: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...
-
Senior MS&T Engineer
4 weeks ago
Fishers, United States INCOG BioPharma Services Full timeJob Functions: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...
