QA Validation Specialist

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.ResponsibilitiesProvide 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.RequirementsExperience 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. Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.