The QA Validation Specialist III is responsible for supporting equipment and cleaning validation activities within a cGMP biopharmaceutical manufacturing environment. This role leads the development and execution of validation protocols, equipment requalification, and validation lifecycle activities to ensure GMP compliance and equipment remains in a validated state. The specialist provides technical support for equipment validation, cleaning validation (CIP/COP/SIP), temperature mapping, autoclaves, clean utilities, and storage systems while collaborating with Quality, Manufacturing, and Engineering teams. The position also supports change controls, deviations, CAPA, SOP development, and quality systems using Kneat, TrackWise, and DMS, ensuring regulatory compliance and audit readiness.
- 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.
- Bachelor's Degree in one of the following disciplines (preferred):
- Chemical Engineering
- Mechanical Engineering
- Biomedical Engineering
- Biotechnology
- Biology
- 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.