The Validation Engineer is responsible for:
Commissioning and qualification Installation and Operational testing protocols (including computer system testing and qualification), reports and supporting documentation and records.
Performance qualification protocols and reports and supporting documentation and records
Author and execute validation studies related to cGMP operations and / or ongoing change controls.
Provide Support to Internal and External Audits
Provide Validation Support for any new equipment and changes to existing equipment
Provide Validation Support for document reviews and assist in Validation Policy/SOP revisions and overall continuous improvements of systems/SOPs/Policy documents
Maintain Validation Master Plan documents and schedules.
Experience in Sterile Operations
Autoclave validation process
Requirements
- Facility Qualification - Execute Facility Qualification Protocol
- Instrument Air - Execute Commissioning Plan
- Instrument Air - Draft Commissioning Plan Final Report
- Autoclave - Execute PQ Protocol
- Masterflex Pump - Execute IQOQ Protocol
- Thermo Scientific 30M Incubator - Execute PQ Protocol
- PHC Incubators - Execute PQ Protocol
- Author and execute Commissioning, IQ/OQ, and PQ for several Manufacturing process equipment.
- BS Engineering
- 5 or more years of experience.
Benefits
Contract Position
Facility Qualification - Execute Facility Qualification Protocol Instrument Air - Execute Commissioning Plan Instrument Air - Draft Commissioning Plan Final Report Autoclave - Execute PQ Protocol Masterflex Pump - Execute IQOQ Protocol Thermo Scientific 30M Incubator - Execute PQ Protocol PHC Incubators - Execute PQ Protocol Author and execute Commissioning, IQ/OQ, and PQ for several Manufacturing process equipment. BS Engineering 5 or more years of experience.