Sr. CSV/CSA/Validation Engineer

About the Role

We are seeking someone strong with GXP applications, SaaS/PaaS, infrastructure, quality, cloud concepts, and cloud applications. In addition to validation and regulation experience, the resource should be able to independently support Business Separation activities for large global and regional GxP computerized systems with minimal supervision.

Responsibilities

• Independently support Business Separation activities for large global and regional GxP Computerized systems with minimal supervision
• Manage end-to-end from inventory and assessments through remediations to final dispositions
• Perform Infrastructure Qualifications and Business Systems Validations
• Define and implement risk-based validation activities
• Write and execute documentation for all aspects of validation deliverables, including Requirements, Compliance/Validation Plans, test protocols, Test Summary reports, Compliance/Validation Reports, and SOPs/WIs
• Review system test and user acceptance test scripts, Traceability matrices, and Design Specs
• Provide validation guidance, timely reviews, and escalations to management
• Lead or advise Junior and Senior resources

Requirements

• Strong CSV expertise, especially within Acquisition/Divestiture/Separation
• 7–10 years of relevant experience
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• Experience in an FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validation
• Experience in QA Methodologies, including designing, reviewing, and approving Test Plans, systems and UAT test scripts, and Test procedures

Skills

• Ability to work as a team player, lead a team, or accomplish tasks without supervision
• Ability to work with remote teams and support several changes/projects simultaneously