Manufacturing Engineer

The Manufacturing Engineer is a key technical role within INCOG Bio Pharma 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.

• 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

• 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

• 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

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.