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Director of Engineering

1 month ago

indianapolis, United States Harba Solutions Inc. Full time

Job Responsibilities:


  • Ensure all equipment, facilities, and automation systems meet current Good Manufacturing Practices (cGMP).
  • Implement a risk-based maintenance approach, regularly conducting assessments to identify critical systems and equipment.
  • Build and sustain a robust reliability program to maximize equipment uptime.
  • Control and monitor environmental conditions to comply with aseptic manufacturing standards.
  • Lead the Engineering team in the design, implementation, and validation of control systems according to Process Validation regulations and guidelines.
  • Ensure automation systems, including Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs), meet regulatory standards for electronic records and signatures.
  • Develop and maintain a Change Control system in line with regulations for managing modifications to control systems.
  • Collaborate with Validation and Quality Assurance teams on risk assessments and validation activities following U.S. and international Process Validation guidelines.
  • Implement advanced process control strategies to optimize production and minimize variability.
  • Develop and manage the site’s capital plan, aligning with strategic objectives and adhering to U.S. and international equipment qualification requirements.
  • Prepare project proposals, perform cost-benefit analyses, and ensure regulatory compliance.
  • Utilize a comprehensive project management system to execute projects on time and within scope and budget.
  • Lead cross-functional teams to drive project success, including engineers, quality professionals, and regulatory experts.
  • Oversee the site-controlled drawing program to ensure compliance with regulatory standards.
  • Work closely with Regulatory Affairs on regulatory submissions and updates, ensuring alignment with U.S. and international requirements.
  • Conduct regular risk assessments to mitigate potential risks related to facility maintenance, control systems, and capital projects.
  • Implement a Corrective and Preventive Action (CAPA) system that adheres to regulatory standards.
  • Collaborate with Research & Development to ensure seamless technology transfer of new pharmaceutical products.
  • Partner with the Quality Assurance department to maintain a robust Quality Management System (QMS).
  • Work with Production to optimize manufacturing processes, reduce waste, and enhance efficiency while ensuring product quality.
  • Report progress, challenges, and opportunities to senior leadership and participate in strategic decision-making.


Qualifications:


  • Bachelor’s degree in Engineering or related field required.
  • 15+ years of relevant experience in cGMP manufacturing, equipment/facility maintenance within biotechnology or pharmaceuticals, or industrial maintenance in a cGMP-regulated environment.
  • 5+ years in a leadership role.
  • Knowledge of automation controls, alert systems, and data collection/retention systems.
  • Understanding of HVAC and clean utility systems.
  • Proven experience in managing capital projects, including cost estimation, capital justification, scheduling, and execution.
  • Familiarity with Total Productive Maintenance, condition monitoring, and predictive maintenance.
  • Experience ensuring cGMP compliance.
  • Expertise in generating equipment qualifications and process validation.
  • Proficiency with CMMS software.
  • Demonstrated ability to lead cross-functional teams and drive cultural changes.
  • Budget and fiscal management experience.
  • Skilled in root cause analysis and corrective actions.
  • Self-directed, able to manage department independently while meeting deliverables and timelines.
  • Excellent communication and presentation skills.