Facilities and Validation Engineer

Location: Durham, NC 27703 | Full-time

About the role

The Facilities and Validation Engineer is responsible for the operation and maintenance (scheduled/emergent) of mechanical systems and equipment in warehouse and manufacturing areas, calibration of instruments and measurable tools, and maintenance and validation of parts and components used in manufacturing. This includes direct troubleshooting, collaboration and oversight with site personnel, equipment, and calibration contractors. The role supports new equipment installations, protocol generation, and field execution to bring equipment online for manufacturing use, and manages records within the company’s ERP equipment module. All activities are performed and documented in compliance with applicable regulatory requirements. Biopharma experience is required.

Responsibilities

• Manage equipment operation in warehouse and cleanrooms, including mechanical troubleshooting, PM scheduling, and vendor interactions related to equipment.
• Work directly within the company’s ERP equipment module to manage equipment records, maintenance activity tracking, calibration schedules, and qualification/validation documentation.
• Identify opportunities for new best-in-class equipment to enhance or replace existing equipment and processes.
• Lead qualification efforts for new equipment installations through IOPQ protocol generation, execution, and completion of site onboarding documentation.
• Manage the equipment calibration program, including scheduling, execution, and recordkeeping for calibrated instruments and measurable tools, in coordination with internal staff and calibration contractors.
• Maintain and validate parts and components used in manufacturing equipment and processes, including planning and executing component engagement studies to confirm proper fit, function, and performance.
• Work cross-functionally on maintenance and validation projects to successfully implement on-site.
• Ensure equipment, calibration, parts, and validation activities are performed and documented in compliance with applicable regulatory requirements (e.g., cGMP, FDA), and support regulatory inspections and customer audits.
• Serve as subject matter expert during customer visits and audits for equipment operation, maintenance records, and qualifications performed.
• Perform other work-related duties as required.

Requirements

• Minimum 1-3 years’ experience in the biopharma industry with preference toward equipment maintenance and troubleshooting and/or equipment validation.
• Familiarity with equipment calibration practices and management of measurable/measuring instruments.
• Working knowledge of regulatory requirements applicable to biopharma manufacturing (e.g., cGMP, FDA).
• Experience working within an ERP, CMMS, or equipment management system.

Qualifications

• Bachelor’s degree in Mechanical Engineering or equivalent field experience.

Skills

• Strong communication, leadership, and organization skills.

Physical demands

• Able to lift up to 50 pounds.
• May be required to stand, walk, sit, and reach with hands and arms.

Work Environment

• Work is normally performed in a climate-controlled office environment and throughout a heated manufacturing and warehouse facility.
• The noise level in the work environment is usually low to moderate.