Senior CSVE: Validation, Data Security & GxP Leadership

4G Clinical, LLC; Wellesley (MA); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health benefits (medical, dental, and

401(k)

Paid sabbatical program

Job summary

4G Clinical, LLC in Wellesley, MA is seeking a Senior Computer Systems Validation Engineer to lead validation efforts for core products and study projects. You will ensure validation plans, testing approaches, and documentation meet GAMP and regulatory requirements, while overseeing data security and infrastructure validation across study deployments.

The role requires 5+ years in CSV or quality roles within regulated environments and a bachelor’s degree in life sciences or engineering.

Qualifications

• 5+ years of experience in Computer Systems Validation or quality-related roles in a regulated environment.
• Extensive knowledge of GAMP, risk-based validation approaches, and 21 CFR Part 11; familiarity with GCP and ICH GCP guidance.

Responsibilities

• Plan and document validation activities and deliverables for core products and study-related projects.
• Provide quality oversight for testing during validation processes.
• Review and approve validation plans and reports; mentor junior CSV staff.
• Collaborate with DevOps to ensure electronic data security and infrastructure validation.
• Participate in audits as a CSV SME and aid cross-functional CSV training.

Skills

GAMP knowledge

GxP understanding

21 CFR Part 11

Quality/regulatory experience

Leadership/mentorship

Education

Bachelor's degree in life sciences or engineering

Job description

4G Clinical, LLC in Wellesley, MA is seeking a Senior Computer Systems Validation Engineer to lead validation efforts for core products and study projects. You will ensure validation plans, testing approaches, and documentation meet GAMP and regulatory requirements, while overseeing data security and infrastructure validation across study deployments.

The role requires 5+ years in CSV or quality roles within regulated environments and a bachelor’s degree in life sciences or engineering.