What are the responsibilities and job description for the Senior Validation Engineer position at 1POINTSYS.COM?
Position: Sr. Validation Engineer (CSV) with decommissioning experience – 100% Onsite
Location: La Verne, CA - Onsite
Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)
Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans
Providing leadership, oversight, and training related to validation activities to multi-functional teams
Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP)
Skill competencies
At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry
Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques
Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality
Demonstrated project management and leadership skills
Proficiency in interacting with contacts, including project teams and vendors
Certified auditor or equivalent experience conducting software-vendor quality audits
Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives
Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP
Experience with the following software systems/applications:
Quality Management System
Document Management System
Validation Management System
Bachelor’s/master’s degree in computer science engineering or equivalent
