CQV Engineer

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior Validation Engineer Responsibilities:

• Lead and execute validation and qualification activities for facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems within GxP-regulated environments.
• Author, review, and approve validation deliverables, including URS, validation plans, risk assessments, protocols, test scripts, IQ/OQ/PQ documentation, deviations, traceability matrices, and validation/qualification summary reports.
• Plan, coordinate, and perform hands-on validation execution, including protocol execution, field verification, system walkdowns, functional testing, punch-list management, and acceptance testing.
• Serve as the validation technical lead for assigned projects, providing direction on validation strategy, scope, execution approach, documentation, and issue resolution.
• Coordinate with Engineering, Quality, Operations, Automation, IT, vendors, and other stakeholders to ensure validation activities, project milestones, and deliverables are completed on schedule.
• Review engineering and vendor documentation, including drawings, specifications, manuals, FAT/SAT documentation, and commissioning records, to establish validation requirements and execution strategies.
• Lead the identification, investigation, and resolution of deviations, discrepancies, change controls, and validation-related issues.
• Ensure validation documentation and execution activities comply with cGMP, GAMP 5, ASTM E2500, data integrity principles, Good Documentation Practices, and applicable regulatory requirements.