Lead CQV Engineer

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes 
  
• Running test scripts and documenting results
  
• Adherence with project schedule for all assigned activities
  
• Maintaining clear, detailed records qualification and validation
  
• Documenting impact and risk assessments as part of a team
  
• Completing user interface testing, software verification, and complete alarm testing on automated systems
  
• Developing, reviewing, and executing testing documentation
  
• Making recommendations for design or process modification based on test results when executing test scripts
  
• General understanding of capital equipment implementation and process knowledge
  
• Understanding validation documents, URS, IQ, OQ, PQ
  

Requirements

• Minimum 12+ years of Work Experience 
  
• Expertise in Production Equipment, Facilities (Clean Room Qualification with EMPQ), and Utilities (WFI, HVAC, Compressed Gases) for the following deliverables:
  
• Reviewing Factory Acceptance Testing (FAT) documentation.
  
• Reviewing and updating URS, System Level Impact Assessments (SLIA), and System Classification Assessments (SCA). 
  
• Authoring Validation Project Plans. 
  
• Authoring Requirements Traceability Matrix (RTM)
  
• Execution support of the following documents:
  
• Receipt Verification (RV) 
  
• Site Acceptance Testing (SAT) protocols.
  
• Commissioning Protocols (IV, OV)
  
•  Drafting and Executing Data Integrity (DI) Assessment
  

• Experience in GMP regulated Environment
  

Benefits