Senior CSV Validation Engineer - Strategy & Compliance

CooperSurgical; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

CooperSurgical in the United States seeks a Senior Computer Systems Validation Engineer to lead the validation, maintenance, and continuous improvement of computerized systems in regulated environments. You will establish and maintain the corporate CSV framework, ensure inspection readiness, and drive a risk-based validation culture.

Responsibilities include leading CSV tasks across lifecycle, guiding governance, mentoring staff, and collaborating with IT, Regulatory, Quality, PMO, and R&D to

Qualifications

• 7+ years of experience in QA and compliance for validated systems.
• Hands-on CS validation, software QA, and QMS documentation.
• Familiarity with CSV, CSA, FDA 21 CFR parts 11/58/211/820/1271.
• Experience with Agile PLM, MasterControl, Veeva, TrackWise or equivalent.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Lead validation tasks across enterprise and high-risk programs throughout the systems life cycle.
• Propose streamlined approaches for CSV strategy and governance to meet compliance.
• Lead validation projects and phases of larger projects (eQMS, Quality Systems).
• Drive inspection readiness and continuous CSV improvement.
• Train and mentor project team personnel in CSV lifecycle methodology.
• Collaborate with IT, manufacturing, quality, infrastructure, PMO and other teams to guide CSV.

Skills

CSV

Quality Assurance

QMS

SDLC

Regulatory knowledge

Cross-functional collaboration

Documentation practices

Microsoft Office

D365

Agile/Waterfall

Education

B.S. in Computer Engineering

Tools

Agile PLM

MasterControl

Veeva

TrackWise

IQVIA

JIRA

ServiceNow

Job description

CooperSurgical in the United States seeks a Senior Computer Systems Validation Engineer to lead the validation, maintenance, and continuous improvement of computerized systems in regulated environments. You will establish and maintain the corporate CSV framework, ensure inspection readiness, and drive a risk-based validation culture.

Responsibilities include leading CSV tasks across lifecycle, guiding governance, mentoring staff, and collaborating with IT, Regulatory, Quality, PMO, and R&D to