Biopharma Facilities & 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

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.