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Snr Validation Engineer

Edison-New Brunswick Metro Area, NJ

Posted: 10/16/2019 Job Type: Scientific Job Number: JN -102019-25824

Job Description

Snr Validation Engineer

The Equipment Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation.

Essential Functions:

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

Develops protocols, and associated reports while adhering to a change management process.

Supports the execution of equipment qualifications and validation protocols

Supervises vendors for qualification functions.

Develops written procedures for calibration and preventive maintenance of equipment

Supports calibration, equipment qualification and validation activities.

Configures and documents the configuration of computerized systems

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems

Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance t


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