TSMS Engineer

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer supports technology transfer, process validation, GMP floor support, and continued process verification for clinical and commercial programs in accordance with current good manufacturing practices (cGMP). The role provides technical oversight to production to help establish robust and reliable manufacturing processes. The engineer autonomously scales up and transfers processes into full-scale manufacturing using internally generated or client-provided data, and serves as a subject matter expert for manufacturing processes. The position represents TSMS on project teams and communicates directly with customers. The role is based at INCOG BioPharma Services’ Fishers, Indiana offices unless otherwise specified. The campus is smoke-free. Applicants must be authorized to work in the United States on a full-time basis; the company does not provide work authorization or visa sponsorship for this role.

Requirements

Bachelor’s degree in Science or Engineering.
1–3 years of GMP experience.
Experience in technical transfer in the pharmaceutical or a related industry.

Nice To Haves

Master’s degree in Science or Engineering.

Responsibilities

Autonomously scale up and transfer processes into full-scale manufacturing based on data generated internally or received from clients.
Select appropriate equipment and single-use components for GMP manufacturing.
Develop technical documentation, including Tech Transfer Plans, Gap Assessments, Process Flow Diagrams, Summary Reports, and Process FMEAs.
Represent TSMS in project teams, communicate directly with customers, and serve as a subject matter expert for manufacturing processes.
Author GMP manufacturing documentation, including Master Batch Records, Bills of Materials, and Processing Forms.
Monitor process data, identify trends, and propose actions as necessary.
Lead 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 groups in support of Process Performance Qualification and Continuous Process Verification.
Collaborate with cross-functional teams to assess and implement new technology for GMP manufacturing.
Assess the impact of changes to products, processes, equipment, procedures, and materials.
Manage timelines and prioritize critical-path tasks to meet deadlines.
Perform other responsibilities as required.