Senior CSV Engineer - Global Validation & Compliance

Curia Aalborg ApS; Hopkinton (MA); On-site; USD 123,000 - 145,000; Full time

Benefits offered by this job

Benefits on day 1

Paid training

Career advancement

Education reimbursement

401K matching

Learning platform

And more!

Job summary

Curia in Hopkinton, MA is seeking a CSV Systems Engineer III to support Quality Management Systems and CSV efforts. You will guide global CSV projects and ensure tools for quality metrics and reports for audits.

This role requires hands-on CSV expertise across lifecycle, risk assessments, validation protocols, and collaboration with IT, Lab Ops and vendors to maintain a validated state and data integrity.

Qualifications

• Bachelor's degree or equivalent in a relevant technical/scientific field.
• 6-8 years of progressive CSV/IT experience in GMP-regulated environments.
• Hands-on experience administering and supporting computerized systems, including security, backups, patching, and vendor coordination.

Responsibilities

• Lead and manage multiple site and global CSV initiatives ensuring systems remain validated and compliant.
• Develop, review, execute, and maintain risk-based CSV deliverables (plans, requirements, protocols, reports, periodic reviews).
• Act as CSV SME providing guidance on validation strategies, SOPs, templates, and lifecycle controls.
• Own and support CSV-related change controls, deviations, CAPAs, investigations, and risk-based guidance for compliance.
• Maintain oversight of computerized systems, including inventory, classification, validation status, and lifecycle documentation.
• Collaborate with IT, Lab Operations, system owners, vendors to ensure controls for security, backups, patches, and infrastructure changes.
• Support CSV during internal and client audits, responses, and remediation activities.
• Coordinate periodic reviews and risk assessments to verify suitability and validation state.
• Provide routine reporting on validation projects, system inventories, and audit observations.

Skills

CSV

Quality Systems

GxP Compliance

IT Administration

Risk Assessment

Education

Bachelor's degree or equivalent in a technical/scientific field

Job description

Curia in Hopkinton, MA is seeking a CSV Systems Engineer III to support Quality Management Systems and CSV efforts. You will guide global CSV projects and ensure tools for quality metrics and reports for audits.

This role requires hands-on CSV expertise across lifecycle, risk assessments, validation protocols, and collaboration with IT, Lab Ops and vendors to maintain a validated state and data integrity.