Location: Dublin
Job Type: Contract
Salary: €60,000 ‒ €75,000
About the job
Overview:
Our client is seeking a Senior 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.
Key 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)
Education / Experience:
* 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