_{27th April, 2026}

SUMMARY
Perform one or more of the following duties and responsibilities in support of  program under minimal supervision.

FUNCTIONS

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment. 

REQUIREMENTS
 

• Doctorate OR Masters + 2 years of experience in Equipment and Validation process OR Bachelors + 4 years of experience in Equipment and Validation process OR Associates + 8 years of experience in Equipment and Validation process OR High school/GED + 10 years of dexperience in Equipment and Validation process
• Sciences or Engineering
• Quality Professional with Equipment, Automation and Validation experience.
• Change control experience.
• In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.

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