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INCOG BioPharma Services · 2 months ago

Tech Transfer Engineer

Fishers, Indiana

Full-time

Onsite

Entry, Mid Level

1+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs. The Technical Transfer Engineer will support all facets of tech transfer, process validation, and GMP floor support while providing technical oversight to ensure robust production processes are established.

BiopharmaBiotechnologyManufacturingPharmaceutical

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

Qualification

GMP experienceTechnical TransferProcess ValidationRoot cause analysisTechnical documentationTechnical oversightCollaborationProject management

Required

Bachelors' degree in Science or Engineering

1-3 years of GMP experience required

Experience in Technical Transfer for pharmaceutical or related industry

Preferred

Masters' degree in Science or Engineering preferred

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees