Validation Engineer.

Ascend PM are hiring a Validation Engineer to join our clients team, a biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to [email protected] to find out more.

Overview

The Validation Engineer will be 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

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