Validation Engineer

Team Horizon is seeking an experienced Validation Engineer to support a new syringe filling line project at our client’s manufacturing facility in 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 globally

What you will be doing:

• 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)

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