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Validation and Instrumentation Specialist

3 months ago

Iron Station, United States Joulé Full time

Job Title: Validation and Instrumentation Specialist
Location: Iron Station, NC area
Schedule / Hours: Monday - Friday, Full Time, Day Shift
Type: Direct Hire

Responsibilities Drives equipment implementation and upgrades within QC.
Coordinate activities with plant metrology.
Perform installation/qualification/validation/verification activities including writing, reviewing, and approval of protocols and reports.
Assist with purchase of new instrumentation including obtaining quotes, completing CAPEX documentation, and providing budget planning regarding equipment needs. Assist with troubleshooting instrumentation issues and space planning with the QC Laboratories.
Drive all activities for validation, qualification, and implementation of new equipment and/or upgrades to existing equipment with QC to ensure timely implementation.
Work cross functionally with Metrology, Engineering, QA, and IT.
Perform accurate and timely review of calibration entries in ProCal.
Communicate with QC & QA as necessary.
Prepare, review, and/or approve engineering change controls (ECC), instrument methods, specifications, protocols, and instrument related SOPs.
Execute IQ/OQ/PQ
Provide coaching to groups and provide technical guidance.
Manage outside contract personnel assisting with equipment implementation/upgrades.
Assist with the purchase of new equipment.

Requirements MS in Chemistry or related scientific field and five years of validation experience in a GMP regulated industry OR
BA/BS in Chemistry or related scientific field and eight years of validation experience in a GMP regulated industry
Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations / requirements
Demonstrate ability to manage projects while executing work to meet established deadlines. Demonstrate knowledge of technical aspects of instrument qualifications including protocol writing, execution, and troubleshooting
Proficient in technical writing
IR, UV/Vis, HPLC, GC, Empower Software, Dissolution, Karl Fischer
Ability to occasionally lift 50 pounds

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