CQV Engineer - Mid

Jacobs   •  

Summit, NJ

Industry: Real Estate & Construction

  •  

8 - 10 years

Posted 57 days ago

This job is no longer available.

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 equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.


Technical/Functional Responsibilities:

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

· Develop CQV planning documents to manage CQV projects

· Generate and execute CQV protocols using Good Documentation Practices (GDPs)

· Investigate and resolve protocol exceptions or discrepancies

· Develop technical reports and CQV summary reports

· Startup 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

· Perform risk assessments and impact assessments

· Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

Qualifications

Minimum Qualifications:

The ideal candidate for this position will possess the following:

  • BS in Mechanical, Chemical or Electrical Engineering or equivalent
  • 8-14 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
  • Flexibility and willingness to travel and work at various clients' locations
  • 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:

· Aseptic processing experience

· Temperature mapping experience

· Cleaning validation experience

· Process validation 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: