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Production Engineer

Lead Candidate, Fishers, IN, USA

Job type: Full Time


Production Engineer
WHAT?
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

position & will cover the hours of

3pm - 11:30pm.
WHO?
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
YOU!
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
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
Why INCOG?
Paid time off, based on tenure
11 paid holidays
401(k) plan with company match up, vested immediately
Choice of health & wellness plans
FSA and HSA options
Onsite wellness facility
Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.