INCOG BioPharma Services Careers - Tech Transfer Engineer

INCOG BioPharma•Fishers, IN

48d•Onsite

About The Position

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.

Requirements

Bachelors' degree in Science or Engineering
1-3 years of GMP experience required
Experience in Technical Transfer for pharmaceutical or related industry

Nice To Haves

Masters' degree in Science or Engineering preferred

Responsibilities

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