CSV Engineer – GxP Systems & Validation Expert

CAI; Rockville (MD); On-site; USD 75,000 - 106,000; Full time

Benefits offered by this job

Comprehensive Health Insurance coverage

24 days of Paid Time Off

15% Company Contribution to 401K (US Only)

Company paid Life Insurance

Company paid Long Term Disability

Job summary

A professional services company is seeking a Computer Systems Validation Specialist in Rockville, MD. The role involves creating GxP documentation, supporting client engagements, and ensuring validation compliance in FDA-regulated industries. Ideal candidates should have a Bachelor's degree in Computer Science or Engineering, with at least 3 years of relevant experience. The position offers a competitive salary between $75,000 and $106,000, along with comprehensive benefits including health insurance and a generous retirement plan.

Qualifications

• Minimum of 3+ years of experience in computer systems validation.
• In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211).
• Experience in biotech or pharmaceutical environments preferred.

Responsibilities

• Author GxP computer validation documentation.
• Generate and execute test protocols and scripts.
• Support client engagements with strong customer-service orientation.

Skills

Excellent oral and written communication skills in English

Strong customer-service orientation

Ability to travel domestically and internationally

Data integrity assessment

Education

Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field

Tools

Rockwell platforms

DeltaV systems

Job description

A professional services company is seeking a Computer Systems Validation Specialist in Rockville, MD. The role involves creating GxP documentation, supporting client engagements, and ensuring validation compliance in FDA-regulated industries. Ideal candidates should have a Bachelor's degree in Computer Science or Engineering, with at least 3 years of relevant experience. The position offers a competitive salary between $75,000 and $106,000, along with comprehensive benefits including health insurance and a generous retirement plan.