QA Validation Specialist 3

Responsible for leading and supporting GMP validation and qualification activities for pharmaceutical manufacturing, laboratory, facility, utility, and computerized systems. Ensures validation programs comply with FDA, cGMP, GxP, and applicable regulatory requirements while managing protocols, testing, deviations, change controls, CAPA, and validation documentation. Collaborates with Engineering, Quality, IT, Manufacturing, and external vendors to maintain inspection readiness and validated state.

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related technical field.
• 5+ years of experience in QA, validation, qualification, or a related GMP-regulated function.
• Hands-on experience with IQ/OQ/PQ and validation lifecycle activities.
• Strong knowledge of cGMP, GxP, FDA, and applicable regulatory requirements.
• Experience developing and reviewing validation protocols, reports, and qualification documentation.
• Experience managing deviations, change controls, CAPA, and validation-related investigations.
• Knowledge of facility, utility, equipment, process, cleaning, or computerized system validation.
• Ability to collaborate with Engineering, Manufacturing, Quality, IT, and external vendors.
• Strong technical writing, documentation, organization, and communication skills.
• Ability to manage multiple validation projects, priorities, and timelines in a fast-paced manufacturing environment.
• Experience supporting regulatory inspections and audit readiness preferred.
• Familiarity with Veeva,
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
• Drive/own the validation plans and execution of equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
• Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA).
• Perform other duties as assigned.