What are the responsibilities and job description for the Validation Engineer position at TekOne IT Services Pvt. Ltd.?
Title: Validation Engineer
Location: Irvine, CA
Duration: 12 Months on W2 Cotract
Responsibilities
Location: Irvine, CA
Duration: 12 Months on W2 Cotract
Responsibilities
- Oversee Computer System Validation (CSV) processes to ensure systems meet regulatory and compliance requirements.
- Maintain up-to-date knowledge of GMP requirements and quality trends, including 21 CFR Part 11, 210, 211, and 820 regulations.
- Independently solve problems and qualify systems within scope, time, and schedule constraints.
- Ensure system qualifications meet regulatory compliance, using industry standards and regulatory guidance.
- Develop and execute system life cycle deliverables such as URS, SRS, FRS, DDS, RTM, IQ, OQ, PQ, Final Validation Summary Reports, and more.
- Develop protocols for validating complex computer systems, including installation, operational, and performance qualifications.
- Collaborate with cross-functional teams and manage personal project timelines effectively.
- Bachelor’s degree in a scientific or engineering discipline.
- Minimum of 5 years of experience in computer systems validation.
- Proven experience in system qualification, regulatory compliance, and industry standards.
- Proficient in developing and executing system life cycle deliverables (e.g., Delta V, FAT, SAT, IQ/OQ/PQ, Validation Planning).
- Strong technical writing and verbal communication skills.
- Ability to work independently and manage own workload.
