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Director of Engineering

Indianapolis $150,000 - $175,000 Contract

Job Responsibilities:

  • Ensure equipment and systems comply with current Good Manufacturing Practice (cGMP) requirements.
  • Conduct regular risk assessments and maintain a reliability program to maximize equipment uptime.
  • Monitor and control environmental conditions for aseptic manufacturing.
  • Lead design, implementation, and validation of control systems in compliance with Process Validation regulations.
  • Ensure automation systems adhere to regulations for electronic records and signatures.
  • Develop and maintain a Change Control system for control systems.
  • Collaborate with Validation and Quality Assurance for risk assessments and qualification activities.
  • Implement advanced process control strategies to optimize production.
  • Develop and maintain the site’s capital plan in line with strategic objectives and equipment qualification requirements.
  • Prepare detailed project proposals, ensuring compliance with regulations.
  • Use a robust Project Management system for project execution.
  • Lead cross-functional project teams to ensure projects meet scope, schedule, and budget targets.
  • Manage the site-controlled drawing program per regulatory guidance.
  • Collaborate with Regulatory Affairs for regulatory filings and updates.
  • Implement a Corrective and Preventive Action (CAPA) system.
  • Collaborate with Research & Development for technology transfer of new products.
  • Engage with Quality Assurance to maintain a robust Quality Management System (QMS).
  • Partner with Production to optimize processes, reduce waste, and enhance efficiency.
  • Communicate progress, challenges, and opportunities to senior leadership.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • 10+ years of relevant experience in cGMP manufacturing, equipment, or facility maintenance in the biotech or pharmaceutical industry.
  • 5+ years in a leadership role.
  • Knowledge of automation controls, alert systems, and data collection/retention systems.
  • Knowledge of HVAC and clean utility systems.
  • Direct experience in equipment qualifications and process validation.
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