| Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: ayush, Scalable Systems [email protected] Reply to: [email protected] Validation Engineer Location: Omaha The Validation Engineer will play a critical role in ensuring the quality and compliance of IT systems within the organization. This individual will be responsible for conducting validation activities, authoring and reviewing project deliverables, and ensuring adherence to regulatory requirements such as 21 CFR Part 11, ALCOA, GxP, GDPR, and SOX.Key Responsibilities: Validation Activities: Conduct comprehensive validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for IT systems. Develop and execute master validation plans and traceability matrices. Manage data migration projects and ensure data integrity. Perform risk assessments and identify potential validation gaps. Regulatory Compliance: Ensure compliance with regulatory requirements, including 21 CFR Part 11, ALCOA, GxP, GDPR, and SOX. Understand and apply relevant regulatory guidelines to validation activities. Documentation and Deliverables: Author, review, and approve validation deliverables, such as validation plans, test scripts, and reports. Maintain accurate and up-to-date documentation for all validation activities. Agile Methodology: Collaborate with cross-functional teams in an agile environment to deliver validation projects on time and within budget. Utilize agile tools and methodologies to manage validation activities effectively. Testing and Quality Assurance: Conduct testing activities using tools like HP ALM, JIRA, qTest, and VERA to ensure system quality and compliance. Perform ERES assessments, audit trail reviews, and risk assessments. Technical Expertise: Demonstrate a strong understanding of pharmaceutical concepts and the CSV lifecycle. Possess hands-on experience with MES validation (FTPS, PMX). Have a solid understanding of HIPAA and SOX compliance requirements.Qualifications and Experience: Bachelor's degree in Computer Science, Information Technology, or a related field. Minimum [Number] years of experience in validation engineering or a similar role within the pharmaceutical industry. Proven expertise in 21 CFR Part 11, ALCOA, GxP, and other relevant regulations. Strong knowledge of validation methodologies and best practices. Proficiency in using testing tools like HP ALM, JIRA, qTest, and VERA. Experience working in an agile development environment. Excellent written and verbal communication skills. Strong attention to detail and organizational skills.Preferred Qualifications: Certification in validation or quality assurance (e.g., CQV, CQA). Experience with MES validation (FTPS, PMX). Knowledge of HIPAA and SOX compliance requirements. Keywords: information technology hewlett packard Validation Engineer [email protected] |
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| Thu Sep 05 19:19:00 UTC 2024 |