Overview
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 (FAT, IVs, FT, SAT and PQs) associated with a Syringe Filling Line.
* Pre-Approve and Post-Approve validation protocols.
* Input into site Validation Master Plans and Standard Operating Procedures (SOPs).
* Collate and report on relevant validation data/metrics.
* Assist in exceptions and deviation resolution and root cause analysis.
* Review Validation planning documents detailing overall strategy for the project.
* Review and Approve Qualification summary reports (QSR).
* Generate Validation Summary reports.
* Assist in the development of User Requirement Specifications (URS) 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.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering and Science
Industries
* Pharmaceutical Manufacturing
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