Senior Validation Engineer, Equipment; Assistance

Senior Validation Engineer specializing in equipment validation within a biopharma manufacturing environment, supporting GMP operations and quality systems.

• develop, review, and execute validation protocols and reports for equipment, systems, and processes
• support validation lifecycle documentation
• troubleshoot and resolve validation issues
• perform root cause analysis
• support change controls, audits, and regulatory inspections
• maintain equipment and asset data
• ensure compliance with GMP, GLP, and QSR standards

• Bachelor’s in science or engineering
• 5+ years of validation experience in cGMP/medical device setting
• strong knowledge of validation lifecycle, industry standards, and regulatory requirements (FDA, EU)
• proficient in validation data systems (e.g., Kaye/Ellab) and standard software
• excellent communication, organization, and independent work skills

• familiarity with computerized systems like BMS, DCS, or SCADA

• equipment validation for manufacturing/quality activities in a biologics or medical device context, supporting validation documentation, change management, and regulatory readiness

hybrid in Jacksonville, FL, with at least four days/week onsite, potential increase to five based on business needs.