QA Validation Specialist 3

Title: QA Validation Specialist 3
Location: Portsmouth, NH
Duration: 6 months

Description:

• 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). Looking for the worker to Build Equipment Re-qualifications in Kneat. 
• 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.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated states.
• 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.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes
• Develop validation protocols from plans and engineering documents.
• Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA)
• Perform other duties as assigned.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.

• Job Summary:
  Equipment Validation Analyst
  Execution of  Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.