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Validation Engineer II in Hatboro, PA, MA. Must have Master’s in Mechanical Engineering and in 2 years of experience the job offered / as Validation Engineer. Will work at various long-term unanticipated worksites.
Duties:
- Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification;
- Write, review and revise a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification
master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional
requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures;
- Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities;
- Write procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments;
- Write and execute protocols, resolve deviations/ discrepancies, review and analyze study data, write summary reports;
- Initiate and perform investigations to close out deviations. Ensure corrective actions are resolved in a timely manner. Support the resolution of regulatory observations or manufacturing
site issues;
- Perform P&ID Walkdowns. Perform Thermal mapping of temperature controlled chambers, warehouses, and SIP processes;
- Provide assistance with project management for commissioning, qualification of new engineering systems;
- Support the resolution of regulatory observations or manufacturing site issues.
Resume: hr@azzur.com, Azzur Group, LLC dba Azzur Consulting, LLC, 330 S. Warminster Road, Suite 341, Hatboro, PA 19040