Production Manufacturing Technician Supervisor

INCOG BioPharma ServicesFishers, IN
Onsite

About The Position

INCOG BioPharma is seeking a highly motivated individual with exceptional mechanical aptitude and subject matter expert (SME) capabilities in the formulation, aseptic filling, inspection, and packaging of sterile drug products. The primary purpose of this role is to provide oversight and leadership to a small team that focuses on: Asset management of manufacturing equipment (routine and preventative maintenance). Troubleshooting, repairing, and resolving mechanical issues to arise in day-to-day manufacturing. Supporting routine technical manufacturing processes; changeover, setup, startup, etc. Optimization and continuous improvement of manufacturing equipment and technologies. Increasing robustness, consistency, and reliability of manufacturing equipment and processing. Overseeing various stages of production, identifying potential areas for improvement and implementing measures to enhance the overall efficiency and effectiveness of the manufacturing operations. The ideal candidate should possess a strong mechanical aptitude and be able to adapt to the changing needs of a manufacturing environment while providing high level guidance and direction to the Engineering Technician team in troubleshooting, repair and preventative maintenance of processing equipment. You will be expected to demonstrate mentor and leadership skills to motivate personnel, drive timely production activities and inspire problem solving & solution driven thinking.

Requirements

  • 3+ years GMP experience with manufacturing processes and equipment in related fields such as biologics, pharmaceutical fill and finish required.
  • 1-3 years of experience in people leadership role
  • Strong communication skill and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.

Nice To Haves

  • Bachelor’s degree in science, Engineering or related scientific discipline preferred.
  • Experience in regulated GMP manufacturing operations preferred.

Responsibilities

  • Lead a small team of Engineering Technicians with strong mechanical aptitude and experience in drug product formulation, filling, visual inspection, and packaging.
  • Provide technical support, oversight, team leadership and guidance in technical decision-making related to manufacturing operations.
  • Lead technical troubleshooting and investigations of manufacturing processes to support root cause analysis, product impact assessment and effective corrective and preventive actions.
  • Implement process improvements based on data analysis and engineering principles; including process design enhancements
  • Provide technical guidance and oversight to Operations and Validation groups.
  • Collaborate with cross-functional teams to troubleshoot and resolve complex technical issues.
  • Own and improve corrective and preventative maintenance strategies, timing, effectiveness, etc.
  • Perform GEMBA walks and checks for process improvements.
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