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Validation Engineer || Pharma
3 months ago
Must Haves:
*Implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites
*Capable of taking Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
Education and Experience:
• Required BS degree in Engineering / Computer Science
• Minimum 5 years of experience in FDA-regulated industry, with min 3 years’ experience in CSV
DUTIES AND RESPONSIBILITIES:
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.
• 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, and Change Controls.
• Manages projects of varying scope and complexity.
• 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 qualification and validation documentation with accuracy, completeness, and compliance to Company standards.
• Provides excellent customer service and support.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
