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# TSMS Engineer

- **Company:** INCOG BioPharma Services
- **Location:** Fishers, IN, United States
- **Experience:** Starter
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Iq/oq/pq, Data Processing
- **Published:** September 10, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=dd71e7377da747f1

## About the Role

* Bachelors' degree in Science or Engineering

 * Masters' degree in Science or Engineering preferred

 * 1-3 years of GMP experience required

 * Experience in Technical Transfer for pharmaceutical or related industry

## Description

The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer 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 production to ensure robust and reliable production processes are established.

Essential Job Functions:

 * The Technical Transfer Engineer is responsible for autonomously 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 TSMS 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

 * Manage timelines and appropriately prioritize critical path tasks to meet deadlines

 * Other responsibilities as required, Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.