Production Engineer - 3rd Shift

Role Overview

The Production Engineer at INCOG BioPharma plays a vital technical role within the Engineering and Technical Operations teams, focusing on maintaining data integrity, implementing advanced digital technologies, managing process control strategies, and supporting the overall technology roadmap. This position is crucial in ensuring efficient and compliant manufacturing processes in pharmaceuticals and biologics, particularly within sterile and aseptic filling environments.

Work Schedule

This full-time role operates during the 3rd shift on Sundays through Thursdays from 11:00 PM to 7:30 AM.

Primary Responsibilities

• Address and resolve daily operational issues promptly, providing effective solutions.
• Collaborate with cross-functional technical teams and site leadership to implement solutions.
• Serve as the subject matter expert for filling equipment and its supporting systems.
• Assess and enhance the efficiency of manufacturing instruments, equipment, and tools.
• Evaluate and enact process improvements and changes.
• Participate in or support process Failure Mode and Effects Analyses (FMEAs) to identify risks ahead of process validation.
• Provide technical support to manufacturing operations.
• Apply Good Engineering Practices (GEP) to promote excellence in both engineering and site operations.
• Coordinate with vendors and suppliers to define and understand functional requirements and specifications.
• Flexibly manage working hours to maintain comprehensive production facility coverage.

Qualifications & Experience

• Bachelor’s degree in engineering or life sciences with at least 5 years of relevant experience.
• Demonstrated understanding of pharmaceutical manufacturing, especially biotechnology products and aseptic fill-finish processes.
• Hands-on experience in troubleshooting, repairing, and performing preventive maintenance on manufacturing equipment.

Preferred Qualifications

• Certification in Lean Six Sigma.
• Practical knowledge of current Good Manufacturing Practices (cGMP) and regulatory standards for pharmaceuticals and medical devices.
• Experience with process design, data integrity, control systems, instrumentation, and electromechanical systems.

About INCOG BioPharma Services

INCOG BioPharma is a leading contract development and manufacturing organization (CDMO) specializing in parenteral injectable drugs. We emphasize a culture of long-term customer value, technical excellence, service orientation, and a collaborative approach. We encourage innovation and continuous improvement to deliver quality outcomes swiftly to market. The position is based in Fishers, IN, on a smoke-free campus.

Diversity, Equity, and Inclusion Statement

INCOG BioPharma is an Equal Opportunity Employer committed to non-discrimination and maintaining a harassment-free workplace. Employment decisions are made based on business needs, job requirements, and individual skills, regardless of race, ethnicity, religion, gender, age, disability, sexual orientation, family or parental status, or other protected status.

Work Authorization

Candidates must be authorized to work full-time in the United States. INCOG BioPharma does not offer sponsorship for work visas or work authorization programs.

Disclaimer

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