GxP CSV Engineer | FDA-Regulated Systems Expert

CAI; Indianapolis (IN); On-site; USD 75,000 - 106,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

24 days of Paid Time Off

15% Company Contribution to 401K

Company paid Life Insurance

Company paid Long Term Disability

Job summary

A professional services company based in Indianapolis seeks a Computer Systems Validation Specialist to support compliance and quality assurance in FDA-regulated industries. Responsibilities include authoring validation documentation and executing test protocols. Applicants should have a bachelor's degree in Computer Science or Engineering and at least 3 years of relevant experience. The role offers a competitive salary between $75,000 and $106,000 annually, along with comprehensive benefits.

Qualifications

• 3+ years of experience in computer systems validation required.
• Experience in biotech or pharmaceutical environments preferred.
• In-depth understanding of GAMP guidelines and FDA regulations.

Responsibilities

• Author validation documentation including URS, FRS.
• Generate and execute test protocols and scripts.
• Support CSV activities across various automation platforms.

Skills

GxP computer validation

Customer service orientation

Data integrity assessment

Excellent communication skills

Problem solving

Education

Bachelor’s degree in Computer Science or Engineering

Tools

Rockwell PharmaSuite

DeltaV

Job description

A professional services company based in Indianapolis seeks a Computer Systems Validation Specialist to support compliance and quality assurance in FDA-regulated industries. Responsibilities include authoring validation documentation and executing test protocols. Applicants should have a bachelor's degree in Computer Science or Engineering and at least 3 years of relevant experience. The role offers a competitive salary between $75,000 and $106,000 annually, along with comprehensive benefits.