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INCOG BioPharma Services · 1 month ago

Tech Transfer Engineer

Fishers, IN

Full-time

Onsite

Entry Level

1+ years exp

INCOG BioPharma Services is a world-class CDMO focused on parenteral injectable drugs. They are seeking a Tech Transfer Engineer to provide direct technical support to manufacturing operations, ensuring compliance with cGMP and assisting in process execution and troubleshooting.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Provide real-time technical support to manufacturing operations staff during production activities across all manufacturing areas

Assist with scaling up and transferring processes into manufacturing by supporting execution of established procedures and protocols

Support equipment setup, operation, and troubleshooting under guidance of senior technical staff

Review and assist with GMP manufacturing documentation including Batch Records, Processing Forms, and standard operating procedures

Monitor Process Data during manufacturing operations and escalate deviations or concerns to senior technical staff

Assist with technical troubleshooting of routine process issues and support root cause analysis activities under supervision

Support Process Performance Qualification and Continuous Process Verification activities by collecting data and assisting with documentation

Participate in cross-functional teams to support manufacturing operations and process improvements

Assist with impact assessments of minor changes to processes, equipment, or procedures under supervision

Support training and development of manufacturing operations staff on technical procedures and best practices

Maintain detailed records of technical support activities and communicate findings to senior technical staff

Ensure all activities comply with cGMP regulations, company SOPs, and safety requirements

Other responsibilities as required

Qualification

GMP experienceTechnical aptitudeProblem-solving skillsPharmaceutical manufacturingMicrosoft Office proficiencyCommunication skillsTeam collaborationFast-paced environment

Required

Bachelor's degree in Science or Engineering required

Strong technical aptitude and problem-solving skills

Excellent communication skills for working with manufacturing operations teams

Ability to work in a fast-paced manufacturing environment

Basic understanding of pharmaceutical manufacturing processes and cGMP requirements

Proficiency in Microsoft Office applications and basic data analysis

Preferred

1-2 years GMP experience 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