Assistant Validation Engineer (CSV)

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Title: Assistant Validation Engineer (CSV)

Location: Warren, NJ
 

The CSV Assistant Engineer supports the successful implementation, deployment, maintenance, and administration of all validated computerized systems in compliance with policies, guidelines, and procedures. Through this work, the validation engineer supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers.  The incumbent in this role, identifies issues or unmet needs and initiates efforts to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will own and/or provide SME input for deviations, investigations and change controls.

Key Responsibilities:

• Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures.
• Develops change controls, validation plans, qualification protocols, associated reports and procedures.
• Executes equipment qualifications, validation protocols, and process improvement studies.
• Schedules and performs periodic review of validated computer systems
• Conducts investigations into qualification failures, develops and implements remediation plans
• Oversees vendors for qualification and metrology functions.
• Initiates, guides and reviews written procedures for calibration and preventive maintenance of stand-alone computerized systems
• Initiates, guides and reviews written procedures for administration of stand-alone computerized systems
• Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques.
• Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity.
• Manages laboratory computer system implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates.
• Assists facilities with new construction and relocation projects which involve computerized systems.
• Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to the company standards.
• Provides technical knowledge and direction as Laboratory Systems Management site representative during interactions with all cross functional groups, as required.
• Promotes and provides excellent customer service and support.
• Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests.
• Provides technical support and guidance on calibration, equipment qualification, system validation, and data management. Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment.
• Promotes and maintains compliance with cor