The role of the Validation Engineer, located in San Francisco, is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements. We are looking for a customer-focused, highly collaborative individual to work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs.
The selected candidate will be responsible to:
Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV). This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.
Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.
Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment
Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.
Gather and analyze metrics and key performance indicators to identify opportunities for process improvement
Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas
Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics
Provide change request control and support for legacy GMP systems
Who you are
In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in
bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.
For this position, you bring the following qualification:
BS in Computer Science, engineering or equivalent degree and/or experience
5 - 8 years of professional IT experience in global regulated organization
Knowledge of Health authority regulations, Risk Management, GxP classification, SDLC, Data classification, documentation standards, Infrastructure Qualification, CSV, Change management principles
Experience in working in a regulated environment and with Computer System Validation
Ability to travel as required up to 25% - Advanced English reading, writing, speaking and listening skills
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...