QA Validation Specialist

About the role

Whitecap is seeking a skilled professional to join our team. The ideal candidate will have extensive experience in equipment and cleaning validation, with a strong proficiency in using Kneat software. This role involves providing expert support across departments, driving validation plans, and ensuring compliance with GMP standards. If you have a background in biopharmaceutical manufacturing and a passion for maintaining high-quality standards, we encourage you to apply.

Responsibilities

• Provide Subject Matter Expert support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
• Drive and 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 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) and TrackWise Quality System (Change Control, Deviation, CAPA).
• Perform other duties as assigned.

Requirements

• Experience with equipment validation and cleaning validation, specifically with Clean-In-Place (CIP), Clean-Out-of-Place (COP), and Steam-In-Place (SIP).
• Proficiency in using Kneat software is absolutely required.
• Experience with Ellab for Temperature Mapping is a plus.
• Experience in drafting Standard Operating Procedures (SOPs) for Cleaning Validation, particularly in Media Hold/Media Fill.
• Experience with Single Use equipment, Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
• Ability to build Equipment Requalifications in Kneat.
• Strong understanding of GMP standards and validation procedures.
• Excellent organizational and communication skills.