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

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

Two River Consulting PartnersSummit, NJ, US
2 days ago
Job type
  • Full-time
Job description

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

  • 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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    Senior Analytical • Summit, NJ, US

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