Facilities and Validation Engineer

United States·Durhammid

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Manage equipment operation in warehouse and cleanrooms, including mechanical troubleshooting, PM scheduling,

Requirements Summary

Manage equipment operation in warehouse and cleanrooms, including mechanical troubleshooting, PM scheduling,

Technical Tools

QA & TestingValidation Engineer

Title: Facilities and Validation Engineer
Job Type: Full-time
Location: Durham, NC 27703

Summary: The Facilities and Validation Engineer is responsible for the operation and maintenance (scheduled / emergent) of the mechanical systems / equipment in the warehouse and manufacturing areas at CCG’s facilities, the calibration of instruments and measurable tools, and the maintenance and validation of parts and components used in manufacturing. This will include direct troubleshooting and collaboration/oversight with site personnel, equipment, and calibration contractors. Additionally, they support new equipment installations, including protocol generation and field execution to bring onboard for manufacturing use, and work directly within the company’s ERP equipment module to manage equipment, maintenance, and calibration records. All activities are performed and documented in compliance with applicable regulatory requirements. Biopharma experience is required for this role.

Essential Duties and 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/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

Desired Education:
Bachelor’s degree in Mechanical Engineering or equivalent field experience

Desired Skills & Experience:

Minimum 1-3 years’ experience in the biopharma industry with preference towards equipment maintenance and troubleshooting and/or equipment validation
Strong communication, leadership, and organization skills
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
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
Job Type: Full-time