What are the responsibilities and job description for the Validation Engineer III position at TekOne IT Services Pvt. Ltd.?
Role: Validation Engineer III
Location: Anasco, PR - 00610(ONSITE)
Duration: 12 Months On W2
Job Description
Location: Anasco, PR - 00610(ONSITE)
Duration: 12 Months On W2
Job Description
- Documentation & Training: Develop and implement documentation, procedures, and training for the engineering team.
- Validation Life Cycle Participation: Actively engage in the validation process, including reviewing validation documentation, performing risk assessments, and developing protocols for testing and validation.
- Validation Documentation: Create validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrices, and validation protocols (FAT/SAT/IQ/OQ/PQ).
- Statistical Analysis: Provide statistical analysis to support validation reports, develop sampling plans, and review results to ensure compliance.
- System Troubleshooting: Troubleshoot automation systems during validation runs and suggest improvements.
- Compliance Monitoring: Ensure compliance with regulations such as FDA, OSHA, ISO, and GMP, and participate in external audits (FDA, Notified Body).
- Non-Conformance & CAPA Investigations: Lead investigations into non-conformance incidents and manage CAPA investigations and reports.
- Equipment Management: Oversee installation, modification, and validation of equipment and automated systems, working with internal teams and external vendors.
- Performance Monitoring: Track and report metrics related to validation system performance, preparing data for Quality Management and Operational Reviews.
- Cross-functional Collaboration: Work closely with Manufacturing, Regulatory, Engineering, and Quality Assurance teams to ensure project success.
- Regulatory Knowledge: In-depth understanding of FDA, OSHA, EPA, ISO standards, GMPs, and validation guidelines (GAMP 5).
- Project Management: Strong project management skills with knowledge of cost control and team leadership for complex projects.
- Validation Expertise: Experience with computer systems validation life cycles, including the development of validation plans and protocols (IQ/OQ/PQ).
- Systems Architecture: Understanding of system architecture, software development methodologies, and associated risks.
- Technical Documentation: Proficiency in writing technical documents such as validation protocols, investigation reports, and SOPs.
- Teamwork & Communication: Excellent communication skills and experience in cross-functional teamwork.
- Experience: 5 years of relevant experience in validation engineering, ideally in regulated environments.