CQV Engineer

• CQV documentation drafting, reviewing and approving CQV documentation
  
• Support ongoing HVAC requalification and new facility qualification
  
• Oversee the start-up and commissioning of new equipment within the Packaging, BDS and Warehouse areas.
  
• Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
  
• Takes part in troubleshooting and remediation project teams.
  
• Be the CQV point of Contact on Site Capital projects, supporting timelines and relevant testing.
  
• Accountable for ensuring activities are scheduled, tracked, and reported appropriately, and achieving project deadlines.
  
• Support the ongoing site requalification program
  
• Leading Risk assessments, root cause analysis and investigations.
  
• Review of protocols, reports, project change controls and deviations.
  

• Understanding and applying industry specific compliance standards/regulations to all CQV activities.
  
• Leading root cause analysis and investigations.
  
• Generation and review of protocols, reports, project change controls and deviations.
  
• Proactively highlighting any issues around compliance.
  
• Participates in internal and external audits and inspections where required.
  

• Planning and execution of all commissioning activities in adherence to site safety procedures.
  
• Operate in a manner consistent with the site incident and injury free philosophy.
  

Requirements

• Technical diploma or Degree in Engineering/Life Sciences or greater preferred
  

• Commissioning, qualification and validation experience in Pharma or Biopharma Manufacturing Facility (min 4 7 years)
  
• Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable
  
• Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
  
• Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
  
• Experience in IMB/FDA environment advantageous.
  
• Experience in HVAC qualification/requalification desirable.
  
• Excellent technical abilities with a solid base in engineering.
  
• Strong technical writing and communication skills.
  
• Proven track record in generation of validation/verification documentation.