Preventative Maintenance Engineer

This role is for a senior engineering professional responsible for independently planning and executing high business impact projects within drug product manufacturing or packaging. The engineer will also act as a SME for facility, equipment, and utilities during regulatory agency audits while managing risk through sound design and fallback strategies.

• Plan and conduct high business impact projects in Drug Product Manufacturing or Packaging
• Develop execution strategy including procurement
• Serve as Facility, Equipment, and Utilities SME during Regulatory Agencies Audits with documentation packages and presentations
• Use sound design, early risk assessments, and fallback strategies to mitigate risk and manage design change consequences
• Maintain project controls and reporting for cost, scope, and schedule

The technical scope focuses on engineering design and execution strategy for drug product manufacturing/packaging, including procurement planning and maintaining project controls for cost, scope, and schedule. The role emphasizes cGMP alignment, audit readiness through documentation packages, and risk mitigation for design changes affecting established processes.

The ideal candidate is a senior preventative maintenance/engineering professional with 6+ years of significant engineering and/or operational experience in drug product manufacturing or packaging. They can independently plan and execute high business impact projects, apply cGMP knowledge, and support Regulatory Agencies Audits with strong documentation and risk assessment skills.