Overview Title: Facilities and Validation Engineer | Job Type: Full-time | Location: Durham, NC 27703Summary 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 equipmentWork 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 processesLead qualification efforts for new equipment installations through IOPQ protocol generation, execution, and completion of site onboarding documentationManage the equipment calibration program, including scheduling, execution, and recordkeeping for calibrated instruments and measurable tools, in coordination with internal staff and calibration contractorsMaintain and validate parts and components used in manufacturing equipment and processes, including planning and executing component engagement studies to confirm proper fit, function, and performanceWork cross-functionally on maintenance and validation projects to successfully implement on-siteEnsure 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 auditsServe as subject matter expert during customer visits and audits for equipment operation, maintenance records, and qualifications performedPerform other work-related duties as requiredDesired Education Bachelor's degree in Mechanical Engineering or equivalent field experienceDesired Skills & Experience Minimum 1-3 years' experience in the biopharma industry with preference towards equipment maintenance and troubleshooting and/or equipment validationStrong communication, leadership, and organization skillsFamiliarity with equipment calibration practices and management of measurable / measuring instrumentsWorking knowledge of regulatory requirements applicable to biopharma manufacturing (e.g., cGMP, FDA)Experience working within an ERP, CMMS, or equipment management systemPhysical demands: Able to lift up to 50 poundsMay be required to stand, walk, sit, and reach with hands and armsWork Environment Work is normally performed in a climate-controlled office environment and throughout a heated manufacturing and warehouse facilityThe noise level in the work environment is usually low to moderateJob Type: Full-time#J-18808-Ljbffr