Validation Engineer-Dublin Contractor

This is a 12-month contract and is an onsite role.

Purpose

• 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
• Onsite position. Once the projects are at certain stages there will be opportunities throughout to do some hybrid work.

Responsibilities

• 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

Qualifications

• 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