TSMS Operations Engineer, 2nd shift

Description

TSMS - Operations Engineer

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.

This is a 2nd shift role, with typical hours from 3:00PM-11:30PM Monday-Friday.

Essential Job Functions:

• 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

Special Job Requirements:

• Bachelor's degree in Science or Engineering required
• 1-2 years of drug product manufacturing 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

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

By submitting your resume and details, you are declaring that the information is correct and accurate.