Description
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 packaging automation, manufacturing, and engineering principles.
The Production Engineer will have the demonstrated ability to apply experience to process design, design thinking, data integrity, controls, instrumentation, and electro-mechanical systems. This position will partner and lead internal operations continuous improvement initiatives.
The ideal candidate must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment while providing high level support to the process engineering and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes. You will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. You will also be expected to demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking. Additionally, this position would act as the owner of the equipment tracking process for manufacturing equipment.
This is an off- shift position
Second Shift (3:00-11:30pm) or Third Shift (11:00pm-7:30am) based on preference
Essential Job Functions:
• Resolve issues that arise in day to day running of operation and providing timely responses and solutions
• Implement solutions in collaboration with cross-functional technical teams and site leadership team
• SME for automated packaging/inspection 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
• Or 10+ years of relevant work experience
Additional Preferences:
• Lean Six Sigma Certification
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
