Senior Validation Expert
2 weeks ago
As a Senior Validation Expert, you will play a pivotal role in ensuring the validation activities associated with our Syringe Filling Lines are in compliance with GMP and quality requirements.
Key Responsibilities:- Develop, execute, review, and approve qualification test documentation, including Factor Acceptance Testing (FAT), Instillation Verification (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT), and Performance Qualifications (PQs).
- Pre-approve and post-approve validation protocols.
- Contribute to site validation master plans and standard operating procedures (SOPs).
- Compile and report on relevant validation data/metrics.
- Assist in resolving exceptions and deviations, as well as root cause analysis.
- Review validation planning documents outlining the overall strategy for the project.
- Approve qualification summary reports (QSR) and generate validation summary reports.
- Support the development of user requirement specifications (URSs) and quality risk assessments for equipment and automated systems (QRAES).
Required Skills and Qualifications:
Experience and Qualifications:- 6+ years of experience in engineering or validation, with a technical qualification at third level or equivalent in engineering.
- Extensive knowledge and demonstrated experience executing validation activities for pharmaceutical/biotechnology projects.
- Experience working with 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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