QA Validation Specialist 3

Roles and Responsibilities

• 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.
• Execute Installation Qualifications/Operational Qualifications and draft Performance Qualifications as required.
• Perform Equipment Validation activities, including Validation Maintenance, Quality Systems reviews, and requalifications to ensure GMP equipment is continuously validated.
• 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), CIP, 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 Standard Operating Procedures (SOPs), Protocols, Change Controls, Deviations, Corrective and Preventive Actions (CAPA).
• Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviations, CAPA).
• Perform other duties as assigned.

Requirements

• Experience with Kneat is absolutely required.
• Experience with Ellab for Temp Mapping is a plus.
• Manager is looking for candidates with Cleaning Val (CIP, COP, SIP).
• 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill.
• Cleaning Val is mostly Drafting SOPs.
• Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
• The role involves Building Equipment Requalification in Kneat.
• The role is Equipment validation and Cleaning Validation.