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INCOG BioPharma Services · 2 months ago

TSMS Operations Engineer, 3rd shift

Fishers, IN

Full-time

Onsite

Entry, Mid Level

2+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers through technical excellence and a collaborative approach. The Manufacturing Science and Technology Engineer will support tech transfer, process validation, and GMP floor support to ensure reliable production processes.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Develop technical documentation such as Process FMEA, Process Flow Diagrams, and Tech Transfer Plans

Select appropriate equipment and single-use components for GMP manufacturing

Recognized as Subject Matter Expert for manufacturing processes in project teams

Author GMP manufacturing documentation including Master Batch Records, BOM, and Processing Forms

Monitor process data, identifying trends and proposing actions

Lead technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventative actions

Provide technical guidance and oversight to Operations and Validation group to support process performance qualification and continuous process verification

Assess the impact of changes to the product, process, equipment, procedures, and/or materials

Qualification

Technical TransferGMP ExperienceProcess ValidationTechnical DocumentationClient-facing Role

Required

Bachelor's degree in science or engineering

2+ years in Technical Transfer for pharmaceutical or similar industry

2+ years GMP experience

1+ year in client-facing role

Preferred

Master's degree 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