Senior CSV Systems Engineer: Validation & Compliance

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

Benefits offered by this job

Generous benefits

Paid time off

Career advancement

Education reimbursement

401K with matching

Learning platform

Job summary

Curia is seeking a CSV Systems Engineer III in Hopkinton, MA to lead sites and global CSV programs, ensuring validated, compliant computerized systems. The role requires extensive CSV lifecycle expertise, regulatory knowledge, and collaboration with IT, QA, and vendors.

The engineer will develop risk-based validation deliverables, support audits, and drive continuous improvement across CSV processes in a GMP environment.

Qualifications

• Bachelor's degree or equivalent in a technical/scientific discipline.
• 6–8 years experience in CSV, Quality, or IT in GMP environments.
• Hands-on experience with system administration, security, backup, patching.
• Experience validating software and systems in GMP manufacturing and labs.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5.

Responsibilities

• Lead and manage site and global CSV initiatives while keeping systems validated.
• Develop and maintain CSV deliverables: plans, protocols, reports.
• Act as CSV SME for guidance on validation strategies and SOPs.
• Own change controls, deviations, CAPAs and investigations.
• Collaborate with IT, QA, and vendors to ensure controls and lifecycle management.
• Report on validation projects and identify process improvements.

Skills

CSV knowledge

GxP/data integrity

System administration

Regulatory compliance

Education

Bachelor's degree in relevant field

Job description

Curia is seeking a CSV Systems Engineer III in Hopkinton, MA to lead sites and global CSV programs, ensuring validated, compliant computerized systems. The role requires extensive CSV lifecycle expertise, regulatory knowledge, and collaboration with IT, QA, and vendors.

The engineer will develop risk-based validation deliverables, support audits, and drive continuous improvement across CSV processes in a GMP environment.