Validation Engineer
1 day ago
Hiring for USA based big MNC, pls Apply if following Job Description suits your aspirations.
We are seeking a meticulous and experienced Validation Engineer to plan, execute, and document validation processes that ensure products, systems, and equipment meet industry standards, regulatory requirements, and company quality criteria. The Validation Engineer will work closely with cross-functional teams in manufacturing, quality, engineering, and regulatory to support product quality and compliance.
- Develop and maintain validation protocols and plans for equipment, processes, software, and systems in compliance with regulatory standards (e.g., FDA, GMP, ISO).
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Prepare and review validation documentation, including protocols, reports, SOPs, and deviation reports.
- Perform risk assessments and root cause analysis to identify and mitigate potential validation issues.
- Ensure validation processes meet industry regulations such as FDA 21 CFR Part 11, GxP, ISO standards, and other relevant guidelines.
- Work with manufacturing, quality assurance, engineering, and IT teams to ensure validation activities are integrated smoothly into operations.
- Recommend and implement improvements to validation processes and protocols.
- Provide training to staff on validation procedures and regulatory requirements.
- Assist in internal and external audits by providing validation records and explanations.
- Assist in internal and external audits by providing validation records and explanations.
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