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Contact Info
Claire Kenny
Life Science

+353 1 507 9287
claire.kenny@lifescience.ie
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Details

Commissioning Qualification Validation (CQV) Engineer


Reference:CK/AFEY-360570 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed

CQV Engineer, Cork (Contract)

Life Science Recruitment is looking for a CQV Engineer to join one of their respected clients in Cork. Experience in the pharmaceutical, medical deviceor biotechnologyindustries is required and a distinct advantage.

Role Overview:

The Commissioning, Qualification and Validation (CQV) Engineer will provide CQV services to clients in the Life Sciences Industry. 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.

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
  • Start-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
  • 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

Requirements:

The ideal candidate for this position will possess the following:

  • BS in Mechanical, Chemical or Electrical Engineering or equivalent
  • 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