INCOG BioPharma Services Careers - TSMS Operations Engineer, 2nd shift

INCOG BioPharma•Fishers, IN

42d

About The Position

The Technical Services and Manufacturing Sciences (TSMS) Operations Engineer will provide direct technical support to manufacturing operations on the production floor in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will work closely with manufacturing operators and supervisors to ensure smooth production operations, troubleshoot technical issues, and support process execution as specified.

Requirements

Bachelor's degree in Science or Engineering required
1-2 years GMP experience preferred
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

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