Provide overall Quality Validation support of manufacturing and in process testing laboratory. Oversee and perform quality approval of Analytical Instrument Qualification (AIQ) and Risk Based C&Q activities following procedures. Performing Equipment Releases for equipment and instruments per local procedures.

Will perform the following duties but not limited to:  Review and Approval of CMMS Change Controls, Work Order Cancelation/Deferment Forms and Validation Forms. Work on a team for quality responsible for instruments undergoing AIQ, C&Q, and review and approve associated documentation. Complete equipment/instrument lifecycle management forms. Complete required release paperwork.  Perform quality review/approval of assessments, protocols, final reports, and standard operating procedures as required. Support activities associated with project execution during routine shutdowns for upgrades and preventative maintenance.

All activities will be executed under the direction Quality Validation personnel.

-Experience Required:

*  Knowledge of Equipment Lifecycle Management Process

*  Validation/Qualification of GxP Lab Equipment and Process Equipment

*  Review and approval of Standard Operating Procedures

*  Computer System Validation and Data Integrity

*  Change Management Process

*  Navigating and recording documentation in electronic systems per Good Documentation Practices

* 5+ Years of Industry Experience

-Systems Experienced Preferred:

*  Document Management Systems

*  Change Control systems (such as Salesforce)

*  SAP

* DeltaV, EMS, BMS, Green Button Go