Associate Director of Engineering

Position Summary

What You Will Do

• Provide scientific and business leadership to ensure departmental performance meets customer expectations and business goals in cost, quality, and turnaround time.
• Drive efficiency and cost-effectiveness within analytical chemistry and microbiology laboratories.
• Serve as a technical escalation point for complex qualification, validation, and facilities-related challenges.
• Apply scientific and engineering principles to develop practical, economical solutions to technical problems.
• Oversee mechanical and electrical aspects of engineering designs by Architect-Engineer firms for systems and facilities, including ISO-certified cleanrooms and HVAC systems.
• Ensure compliance with CGMP regulations, internal SOPs, and equipment lifecycle best practices.
• Lead staff selection, development, and performance management for the Engineering team.
• Develop and execute IQ, OQ, and PQ protocols for laboratory equipment in compliance with GDP guidelines and internal quality standards.
• Troubleshoot and investigate equipment and system issues.
• Lead client-facing projects involving facility assessments, equipment and utility qualification, process and cleaning validation, environmental system design review, and certification readiness.
• Analyze and interpret data, technical drawings, manuals, and schematics to resolve laboratory and facility issues.
• Partner with executive leadership and cross-functional teams to support strategic initiatives.
• Ensure facilities operate safely and comply with all federal, state, and local codes/regulations.
• Maintain compliance with DEA, FDA, and Texas Department of Public Safety requirements.
• Support investigations, deviation management, and CAPA development related to engineering systems and equipment failures.
• Plan, execute, and document engineering workstreams effectively.
• Manage independent projects for internal and external clients.
• Travel up to 30% to support client engagements and site operations.

Who You Are

• Bachelor’s degree in mechanical engineering, chemical engineering, or electrical engineering; MS preferred. 
• Ten years’ engineering experience (15 preferred).  
• Five years of demonstrated knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) specific to Validation of Analytical methods. 
• Strong technical expertise in cleanroom certification standards, utility qualification, equipment lifecycle management and IQ/OQ/PQ execution, process validation, and change control systems.
• Excellent analytical and interpersonal skills. 
• Excellent verbal and written communication skills. 
• Advanced level computer skills. 
• Advanced technical degree, a plus. 

Certifications

• PE preferred