Production Engineer, 2nd Shift

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. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.  This is a 2nd Shift opportunity.   Essential Job Functions: 

• 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

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