Job Description:
We are 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.
Key Responsibilities:
* Generation, execution, review, and approval of CQV test documentation (Factor Acceptance Testing (FAT), Installation Verification (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT), and Performance Qualifications (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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Requirements:
* 6+ years of 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
Skills:
* Validation
* GMP
* Biotechnology