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Validation Specialist
2 months ago
Azzur Group is seeking a highly skilled Computer System Validation Engineer to join our team. As a CSV Engineer, you will play a critical role in ensuring the compliance of our computerized systems with regulatory requirements.
Key Responsibilities- Lead Validation Efforts: Develop and execute validation plans, risk assessments, and other validation deliverables to ensure compliance with 21 CFR Part 11, Annex 11, and GAMP5 requirements.
- Collaborate with Cross-Functional Teams: Work with project teams to determine which elements should be validated and conduct impact assessments of proposed changes to computerized systems.
- Review and Approve Validation Deliverables: Review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
- Develop and Maintain SOPs: Create, review, and update SOPs, forms, templates, documentation, and files to ensure compliance with regulatory requirements.
- Perform Other Duties: Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.
- Education: Master's Degree with 5 years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Experience: Bachelor's Degree with 7 years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Skills: Working knowledge of engineering principles, computerized systems validation, and regulatory requirements such as 21 CFR Part 11, Annex 11, and GAMP5.
- Software: Proficiency in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
- Knowledge of DeltaV Automation Platform: Experience with DeltaV automation platform is preferred.
