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CQV Engineer in Summit, NJ at NextGen

Date Posted: 5/29/2019

Job Snapshot

  • Employee Type:
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

CQV Engineer

6 Months contract to start

Summit, NJ 07901



Job Description

The Commissioning, Qualification and Validation (CQV) Engineer will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products.

This position shall be responsible for the development and execution of CQV documentation on a variety of lab equipment including: Balance, pH meter, HPR, GC, KF Titrator, Milli Q, HPLC, UPLC Disintegrator, LCMS, LC, Dissolution Station, Moisture Analyzer.

Technical/Functional Responsibilities:

Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices:

  • Generate and execute IQ/OQ protocols using Good Documentation Practices (GDPs)
  • Investigate and resolve protocol exceptions or discrepancies
  • Develop technical reports and CQV summary reports
  • Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation
  • Apply engineering knowledge of, and experience with the following lab equipment to support client's needs: Balance, pH meter, HPR, GC, KF Titrator, Milli Q, HPLC, UPLC Disintegrator, LCMS, LC, Dissolution Station, Moisture Analyzer.

Minimum Qualifications:

  • BS in Mechanical, Chemical or Electrical Engineering or equivalent
  • 3-10 years of CQV experience in the life sciences industry
  • Understanding of Good Manufacturing Practices (GMPs)
  • Technical writing skills
  • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project
  • Ability to work well with diverse, multi-disciplined groups
  • Ability to effectively communicate with management and fellow project team members
  • Ability to negotiate/compromise with other project team members to achieve project goals
  • Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements

Preferred Qualifications:

  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
  • Knowledge of industry guidance:
    • ISPE Baseline Guide 5 Commissioning and Qualification
    • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
    • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
    • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
  • Six Sigma Certification