The Sr. CSV/CSA/Validation Engineer leads and independently executes computerized system validation, computer software assurance, infrastructure qualification, and business system validation activities within GxP-regulated pharmaceutical, biotechnology, or medical device environments. The role supports complex global systems, cloud/SaaS/PaaS applications, and business separation, acquisition, divestiture, and remediation initiatives while ensuring compliance with FDA and global regulatory requirements.
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
- Define and implement Risk based validation activities.
- Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs).
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
- Bachelor's degree in Computer Science, Information Technology, Computer Engineering, Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field.
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.
- Ability to provide Validation guidance, timely reviews, and escalations to management
- Need someone strong with gxp applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc.
- In addition to validation and regulation experience, the resource should have the following experience:
- Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison.
- Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
- Ability to manage end-end from Inventory, assessments, remediations to final dispositions;
- Infrastructure Qualifications & Business Systems Validations 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.
- Specifically in the Pharmaceutical, biotechnology, or medical device industry.