Director of Engineering and Maintenance in Dane County

Job Description

Director of Engineering and Maintenance

Our client is a GMP-regulated life sciences manufacturer seeking a senior engineering leader to anchor their operations. This is a high-visibility role where your decisions directly protect product quality, operational uptime, and regulatory standing - all at once.

Why you should apply

• Own engineering strategy across maintenance, utilities, EHS, and systems compliance in a regulated environment
• Lead a cross-functional team with a mandate to drive standardization and continuous improvement
• Shape the GMP and data integrity posture of the engineering function from the top down
• High organizational visibility - your work directly determines audit readiness and production continuity

What you'll be doing

• Oversee preventive and corrective maintenance programs across all facilities and equipment
• Build lifecycle management systems for equipment and utilities, driving standardization and uptime
• Lead computerized system validation (CSV) and enforce data integrity across GxP-regulated systems
• Coordinate with Quality on deviations, CAPA, and change control activities
• Own EHS compliance - OSHA, EPA, and internal safety programs - including regular site inspections
• Drive spare parts classification, master data standardization, and ERP-integrated inventory management

About you

• Be able to do the job as described
• Deep GMP manufacturing experience - you know what audit-ready looks like
• 5+ years of Pharmaceutical CDMO manufacturing experience
• 3+ years of Leadership experience
• Hands-on with computerized system validation (GAMP 5, 21 CFR Part 11)
• Track record managing utilities, maintenance programs, and cross-functional technical teams
• Strong OSHA and EPA compliance background