Equipment Validation Analyst / QA Validation Specialist 3
About The Position
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
- 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.
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.
- 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.
Benefits
- Medical
- Dental
- Vision
- Retirement options
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
