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NextGen Person

CQV Engineer in Summit, NJ at NextGen

Date Posted: 3/29/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    3/29/2019

Job Description

CQV Engineer

6 Months contract to start

Summit, NJ 07901

8am-5pm

M-F

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