Facilities and Validation Engineer

carolinacomponentsgroup; Durham (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Carolina Components Group seeks a Facilities and Validation Engineer to operate and maintain mechanical systems in warehouse and manufacturing areas, calibrate instruments, and validate parts used in production. The role includes protocol generation for new equipment and field execution to bring on for manufacturing use, with documentation in the ERP equipment module.

Biopharma experience is required, and you will ensure compliance with cGMP and FDA regulations.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent required.
• 1–3 years biopharma experience preferred in equipment maintenance/validation.
• Strong communication, leadership and organizational skills.
• Familiar with calibration practices and regulatory requirements (cGMP, FDA).

Responsibilities

• Manage equipment operation in warehouse and cleanrooms, including mechanical troubleshooting and PM scheduling.
• Work within ERP/CMMS to track equipment records, maintenance and calibration documentation.
• Identify opportunities for new equipment to enhance processes.
• Lead qualification for new installations via IOPQ protocol and site onboarding.
• Maintain and manage calibration programs for instruments and tools.
• Validate parts and components and coordinate with internal staff and contractors.

Skills

Biopharma experience

Equipment maintenance

Calibration practices

Regulatory compliance

ERP/CMMS experience

Communication

Leadership

Organizational skills

Education

Bachelor's degree in Mechanical Engineering

Tools

ERP system

CMMS

Calibration tools

Job description

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