- Pleasanton, California, United States
- On-site
- Full-time · Mid
- $94K–$175K per year
- 6+ years
Coordinate and advise on all validation activities on a global/organizational level for each assigned system/project, author and review validation documentation, support system audit inspection readiness, and lead Computerized System Periodic Reviews.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
- Coordinate and advise on all validation activities on a global/organizational level
- Author and review various validation documentation and deliverables
- Support system audit inspection readiness
- Lead and author Computerized System Periodic Reviews
- Assess changes to determine potential impact to the validated state of the computerized system
Requirements
- Bachelor’s degree in science/engineering/computer science
- Nice to have: Agile software development methodologies (Scrum and/or SAFe)
- Nice to have: Product Development Process (PDP) for Medical Devices