Validation Specialist IV
Validation Specialist IV
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements process parameters and global regulatory guidelines. The role provides Operations Quality Assurance and regulatory bodies with scientifically sound documented evidence that systems and processes will perform as required so they can be assured of a quality compliant manufacturing environment.
Roles & Responsibilities:
- 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) 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) Laboratory Information Management System (LIMS) and Track Wise Quality System (Change Control Deviation CAPA).
- Perform other duties as assigned.
- 4-year degree strongly preferred.
- 4 years experience in Mfg.
Employment Type
Full Time
