Job Description

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.

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