CQV Engineer

US$0.00 - US$60.00 per hour
  1. Permanent
  2. Validation
  3. United States
New Jersey
Posting date: 29 Apr 2019
EN.JE.22955_1556549675

A leading civil engineering firm is recruiting a CQV Engineer to join their office in New Jersey. ProClinical is happy to announce this opportunity to work with an internationally recognised organization that provides a full spectrum of services including scientific, technical, professional and construction- and program-management for business, industrial, commercial, government and infrastructure sectors.

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 an Environmental Monitoring System (EMS).

Job Responsibilities:

  • Generate and execute IQ/OQ protocols using Good Documentation Practices (GDPs) to validate an Environmental Monitoring System (EMS).
  • Investigate and resolve protocol exceptions or discrepancies.
  • Develop technical reports and CQV summary reports.
  • Starting up equipment in a safe and effective manner.
  • Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)
  • 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 an Environmental Monitoring System (EMS) to support client's needs.

Skills and Requirements:

  • 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).
  • Aseptic processing experience
  • Ability to use test and measurement equipment (e.g., KAYE Validators)
  • 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.
  • Demonstrated project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joseph Emmott at +44 203 814 1316 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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