Director of Engineering

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.