5-7 years experience in equipment validation and cleaning validation processes.
Proficient with Kneat software; familiarity with Ellab for temperature mapping is an advantage.
Experience with single-use equipment and its validation in biopharmaceutical contexts.
Strong knowledge of biopharmaceutical manufacturing procedures, particularly CIP and SIP.
Demonstrated ability to draft SOPs and validation protocols from engineering documents.
Responsibilities
Provide expert support for quality control and manufacturing departments regarding equipment operation and troubleshooting.
Lead the validation process for equipment changes and oversee process improvements.
Conduct Installation Qualifications and Operational Qualifications, and draft Performance Qualifications as needed.
Engage in the validation maintenance review to ensure compliance with GMP and continuous equipment validation.
Organize and maintain validation equipment and supplies to support compliance activities.
Develop detailed validation protocols from engineering specifications and plans.
Support technical review processes for SOPs, protocols, change controls, deviations, and CAPA within the quality systems.
Benefits
Collaborative work environment with cross-departmental support.
Opportunities for professional development and skill enhancement.
Work with cutting-edge biopharmaceutical manufacturing technology.
Involvement in impactful quality control processes that ensure product safety.
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.
