Equipment Validation Analyst

Responsibilities

• Provide Subject Matter Expert (SME) support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
• Drive and own validation plans and execution for equipment changes and process improvements.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and draft Performance Qualification (PQ) protocols as required.
• Perform equipment validation activities, including validation maintenance, quality systems review, and equipment requalification to ensure GMP equipment remains in a validated state.
• Program, organize, and maintain validation equipment and supplies, including dataloggers and probes.
• Develop validation protocols from validation plans and engineering documents.
• Provide technical support during the review and approval of SOPs, protocols, change controls, deviations, and CAPA documentation.
• Perform Quality Systems activities within the Document Management System (DMS) and TrackWise Quality System, including Change Control, Deviations, and CAPA.
• Perform other duties as assigned.

Requirements

• Experience with Kneat is required.
• Experience with Ellab for temperature mapping is preferred.
• Experience with Equipment Validation and Cleaning Validation.
• Experience with Clean-In-Place (CIP), Clean-Out-of-Place (COP), and Steam-In-Place (SIP).
• Experience drafting SOPs related to cleaning validation.
• Experience building equipment requalification’s in Kneat.
• General understanding of biopharmaceutical manufacturing equipment and validation procedures, including, IV/IQ, IQ, Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping and Controlled Storage Rooms and Equipment.
• Experience developing validation protocols from engineering documents and validation plans.
• Experience reviewing and supporting SOPs, protocols, change controls, deviations, and CAPA documentation.
• Experience working with Document Management Systems (DMS) and TrackWise Quality System (Change Control, Deviations, and CAPA).

Skills

• Subject Matter Expert (SME) support for equipment design, operation, and troubleshooting.
• Validation planning and execution for equipment changes and process improvements.
• Installation, operational, and performance qualification protocols.
• Equipment validation activities, including validation maintenance, quality systems review, and equipment requalification.
• Development of validation protocols from engineering documents and validation plans.
• Technical support during the review and approval of SOPs, protocols, change controls, deviations, and CAPA documentation.
• Quality Systems activities within the Document Management System (DMS) and TrackWise Quality System (Change Control, Deviations, and CAPA).

Benefits

• Equal Opportunity/Affirmative Action Employer (m/f/d/v)

Pay

• $45 to $55 Depending on experience

Schedule

• 1st Shift