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
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.
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