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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
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 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
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