Job Description:
Notes from intake - Role is Equipment validation and Cleaning Validation
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 Requalifications in Kneat.
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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.