Associate Director, Engineering & Automation
The Associate Director oversees equipment and system performance in an FDA-regulated manufacturing facility. They lead a team of engineers, ensuring equipment readiness, troubleshooting issues, maintaining compliance, and driving continuous improvement.
Key Responsibilities:
- Oversee day-to-day equipment performance, qualification status, and change controls.
- Manage utility systems, process/building automation, HVAC, and process equipment.
- Develop and improve operational strategies, optimizing procedures for existing processes and new product introductions.
- Coordinate with Project Engineering, Validation, Maintenance, Manufacturing, Process Development, and Quality Assurance.
- Represent the function to clients, auditors, and inspectors.
- Direct and approve engineering documentation and reports.
Team Leadership & Development:
- Manage full-time employees and contractors, ensuring proper onboarding, training, and resource allocation.
- Provide technical and managerial support for cross-functional teams.
- Foster staff development and work-life balance.
Requirements:
- Education & Experience: Bachelor's degree in engineering and 5+ years in FDA-regulated manufacturing.
- Technical Skills: Strong knowledge of cGMP, engineering practices, equipment design, and regulatory requirements (FDA, EU, ICH).
- Regulatory & Compliance: Ability to assess risks and ensure adherence to quality systems.
- Project Management: Experience managing timelines, resources, and deliverables.
- Computer Proficiency: MS Office, engineering software, and electronic document management systems.
Preferred Skills:
- Experience with control system software (i.e Allen Bradley PLC)and MS Project.
- Understanding of facility and process support equipment.
This role requires strong leadership, technical expertise, and a commitment to quality and compliance in a dynamic manufacturing environment.
