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Director of Engineering and Maintenance

Jacobs Management Group, Inc.

US · On-site Full-time Executive Today

About the role

About Our Client

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

Skills

21 CFR Part 11CAPACSVEHSEPAERPGAMP 5GMPOSHA

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