Senior Validation Engineer

Team Horizon is seeking a Validation Engineers for a leading pharmaceutical company in South Dublin.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.
  
  
• Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
  
  
• Pre-Approve and Post-Approve validation protocols.
  
  
• Input into site Validation Master Plans and Standard Operating Procedures (SOP’s)
  
  
• Collate and Report on relevant validation data/metrics.
  
  
• Assist in exceptions and deviation resolution and root cause analysis.
  
  
• Reviews Validation planning documents detailing overall strategy for the project.
  
  
• Reviews and Approves Qualification summary reports (QSR)
  
  
• Generates Validation Summary reports.
  
  
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
  
  
• Any other duties as assigned.
  
  What you need to apply:
  
  
• 6+ years experience in Engineering or Validation Technical qualification at third level or equivalent in Engineering.
  
  
• Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
  
  
• Knowledge of safety and GMP requirements.
  
  
• Demonstrated strong Communication skills.
  
  
• Experience using Paperless Qualification Systems is preferred.
  
  
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry