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Engineering Jobs in Portsmouth, NH

QA Validation Specialist 3

Katalyst Healthcares & Life Sciences
  • Portsmouth, NH
  • Instant Apply
30+ days ago

Job Description

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.
  • 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.
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). Looking for the worker to Build Equipment Requalification in Kneat.
  • Role is Equipment validation and Cleaning Validation.

Numbers & Facts

LocationPortsmouth, NH

Skills

  • Autoclaveunmatched
  • CIP (Clean-in-Place)unmatched
  • Change Controlunmatched
  • Cleaning Equipmentunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Document Managementunmatched
  • Equipment Maintenance/Repairunmatched
  • Equipment Validationunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Manufacturingunmatched
  • Manufacturing Equipmentunmatched
  • Manufacturing Equipment Maintenanceunmatched
  • Process Improvementunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • SIP (Session Initiation Protocol)unmatched
  • SIP (Sterilization-in-Place)unmatched
  • Standard Operating Procedures (SOP)unmatched
  • Technical Supportunmatched
  • Temperature Mappingunmatched
  • Testingunmatched
  • Validation Planunmatched

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