0013V Senior CSV Analytical Instrument Engineer / Senior Validation Engineer Consultant

Job Description

Job Description

Looking for a strong   resource with a diverse skillset focused around Analytical Instruments accompanied by a thorough understanding of CSV principles.

• Knowledge and demonstrated experience of Computerized System and Analytical Equipment Validation
• Running test scripts and documenting results
• Experience working with IT and troubleshooting
• Experience with requirements gathering and root cause analysis activities
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed, and compliant qualification and validation records
• Understanding of system design and / or configuration activities
• General understanding of capital equipment implementation and process knowledge.
• Understanding with demonstrated experience drafting and executing validation documents, such as, Val Plans, URS, IQ / OQ / PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
• Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• Conducting and documenting impact and risk assessments with a full understanding of equipment / system / software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.

REQUIREMENTS

LOCATION

On-site in Summit, NJ

EMPLOYMENT

C2C or W2 Contractor

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