5-7 years of experience in equipment validation and cleaning validation
Proficient in using Kneat software; experience with Ellab for temperature mapping is advantageous
Knowledge of biopharmaceutical manufacturing equipment and relevant validation procedures
Experience in developing validation protocols from engineering documents
Familiarity with Quality Systems including SOPs, Change Control, and CAPA
Responsibilities
Provide expert support for quality control and manufacturing processes
Own and drive validation plans for equipment changes and process improvements
Execute Installation Qualifications and draft Performance Qualifications as needed
Perform equipment validation including maintenance of Quality Systems
Organize and manage validation equipment and supplies effectively
Develop validation protocols based on engineering specifications
Support the review and approval of scientific documents and protocols
Benefits
Collaborative and supportive work environment
Opportunities for professional development
Involvement with cutting-edge biopharmaceutical technologies
Potential for career advancement within the company
Full 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.
