Validation Engineer Level 3
Location: Santa Clara, California
The validation group is responsible for the & qualification of our customizable software. Used for the control of integrated bioreactor & bioprocessing systems
•Writing, reviewing, and executing customer FAT, SAT, and IQ/OQ protocols for standard & customized systems.
•Working closely with customers hosting FATs at the Santa Clara site.
•Raise discrepancies and close out test documentation.
•Prepare validation summary reports for executed protocols
•Conduct deviation investigations, such as validation failures, complaints and hold investigations. To Identify & implement the appropriate corrective actions.
•Attend client sites to support the C&Q effort US & Worldwide.
•Troubleshoot technical issues and execute corrective actions.
•Act as point of contact for C&Q with clients while site based.
•Ability to travel 20%-30%
•Other duties as assigned.
•BS/BA or equivalent experience in engineering or another scientific field.
•Minimum of 5 years’ experience in control systems testing, preferably within the biotech or pharmaceutical sector.
•Minimum of 5 years of hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
•Computer Systems Validation
•Good understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems.
•Attention to detail and ability to identify and remediate issues found during testing.
•Self-motivated, proactive, and capable of adhering to strict deadlines
•Experience with DeltaV or similar automation system.
•Highly effective verbal and written skills, including technical authorship.
•Proficient in Microsoft Office, particularly Microsoft Word and Excel