What are the responsibilities and job description for the Validation Engineer position at TekOne IT Services Pvt. Ltd.?
Role: Validation Engineer II (Medical Device)
Location: Carlsbad, CA
Duration: 8 Months on W2
Shift: 8 AM to 5 PM (On-Site)
Main Purpose
Location: Carlsbad, CA
Duration: 8 Months on W2
Shift: 8 AM to 5 PM (On-Site)
Main Purpose
- Responsible for creating and implementing the validation program. This includes maintaining validation documentation for systems and processes under design control, ensuring compliance with the Quality Systems Manual.
- Represent internal/external audits of validation projects.
- Write and manage validation documentation in compliance with regulatory standards.
- Oversee the execution of validation protocols to ensure timely and cost-efficient completion.
- Evaluate validation results and summarize them in final reports.
- Manage Validation Master Plans (VMPs) and related reports.
- Assess validation requirements for changes in documents, systems, and processes.
- Track and report validation progress using departmental tools.
- Lead projects of moderate scope and mentor less experienced staff.
- Plan, organize, and prioritize daily work to meet schedules.
- Bachelor’s Degree in a related field or equivalent experience required.
- Master’s Degree preferred.
