Atlanta Metro Area, GA
The Validation Engineer will lead and/or assist validation efforts at. The position will be responsible for preparing the validation strategy and guidance via the review, writing, and executing validation activities. The Validation Engineer will provide the coordination and execution of qualification and validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support R&D VC facilities. In addition Validation Engineer will have an understanding of how the various pieces of R&D equipment operate, and understand the principle of Validation and Engineering to ensure compliance with 21 CFR requirements and R&D VC policies and procedures. The position will require hands-on experience in all areas of validation including equipment qualification, performance qualification, process validation, cleaning validation, computer system validation, and facility utilities qualification.
- Execution of validation plans and validation protocols for VC R&D projects that impact facility, processes, equipment, cleaning, and software systems.
- Prepare and /or revise validation protocols/procedures as required.
- Review and execute qualification and summary reports, write and revise as needed.
- Update the site master validation plan to reflect current validation status.
- Participate in review of R&D operational SOPs that apply to validated equipment, facilities and processes.
- Assist in troubleshooting, complex or usual problems arising from equipment/system failures.
- Ensure continuous validation maintenance for equipment, facility and process through the change control program.
- Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.
- Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
- Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
- BS degree in Mechanical, Electrical Engineering or
Working knowledge of Windchill