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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.
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
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
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
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