Senior CSV Engineer — Regulatory Validation Leader

Regulatory Jobs; United States; Remote; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Senior Computer Systems Validation Engineer to lead validation activities for global computerized systems in regulated environments. You will drive the corporate CSV framework, oversee critical programs, and ensure inspection readiness across the organization.

You will partner with IT, QA, Regulatory, PMO, and R&D to define requirements, risk assessments, and test documentation. Strong leadership and communication are essential in this role.

Qualifications

• Bachelor's degree in Computer Engineering or a related field.
• 5+ years of Computer Systems Validation experience in QA/compliance environments.
• Experience with CSV/QMS systems and regulatory inspections.

Responsibilities

• Lead CSV tasks and deliverables across system lifecycles.
• Guide CSV strategy and governance for compliance and CSA.
• Mentor project teams in lifecycle methodology and testing.
• Ensure inspection readiness and documentation for regulatory audits.

Skills

CSV

Quality Assurance

Regulatory compliance

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Computer Engineering or related field

Tools

Agile PLM

MasterControl

IQVIA

JIRA

Job description

CooperSurgical is seeking a Senior Computer Systems Validation Engineer to lead validation activities for global computerized systems in regulated environments. You will drive the corporate CSV framework, oversee critical programs, and ensure inspection readiness across the organization.

You will partner with IT, QA, Regulatory, PMO, and R&D to define requirements, risk assessments, and test documentation. Strong leadership and communication are essential in this role.