QA Validation Specialist 3

Responsibilities

• Provide Subject Matter Expert support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
• Drive and own validation plans and execution of equipment changes and process improvements.
• Execute Installation Qualifications (IQ) and Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as required.
• Perform Equipment Validation activities, including Validation Maintenance Quality Systems review and requalification to ensure GMP equipment remains 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, and Temperature Mapping of 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) and TrackWise Quality System (Change Control, Deviation, CAPA).
• Perform other duties as assigned.

Requirements

• Experience with Kneat is absolutely required.
• Experience with Ellab for Temperature Mapping is a plus.
• Experience with Cleaning Validation (CIP, COP, SIP), including drafting SOPs.
• Ability to build Equipment Requalification in Kneat.
• Familiarity with Single Use equipment (95% of equipment in this role), Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
• Role focuses on Equipment Validation and Cleaning Validation.