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

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 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   Powered by JazzHR