Production Engineer, 3rd shift

About the role

The Production Engineer is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map. This Engineer will operate during 3rd shift, typically holding hours Sunday-Thursday from 11:00PM-7:30AM.

Responsibilities

• Resolve issues that arise per daily operation and provide timely responses and solutions
• Implement solutions in collaboration with cross-functional technical teams and site leadership
• SME for filling equipment and supporting systems
• Evaluate and improve efficiency of manufacturing instruments, equipment, and tools
• Evaluate and implement new changes
• Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation
• Provide technical support to manufacturing activities
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence
• Partner with vendors and suppliers to define requirements and understand functional specifications
• Work flexible hours to ensure production facility coverage

Minimum Education and Experience

• Bachelor's degree in engineering field or life sciences with 5+ years of relevant work experience
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
• Hands-on experience troubleshooting, repairing and performing preventative maintenance of manufacturing equipment

Additional Preferences

• Lean Six Sigma Certification
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
• Applicable experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems

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.