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

Job Description

Job DescriptionLooking for a strongresource 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

• Bachelor’s Degree or equivalent required
• 4 to 6 year of relevant role specific experience
• Proficiency using PC and Microsoft Office tools
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• Experience in pharmaceutical cGxP setting with the ability to generate CSV/CQV deliverables
• Knowledge of 21CFR Part 11 Regulation
• Ability to work as part of a team
• Direct experience and understanding of complex automated lab and manufacturing systems

LOCATION
On-site in Summit, NJ

EMPLOYMENT
C2C or W2 Contractor

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