BioPharma CSV Engineer: GxP Systems, 21 CFR 11

Cagents; Rockville (MD); On-site; USD 75,000 - 95,000; Full time

Job summary

Cagents based in Rockville, MD, seeks a Computer Systems Validation Specialist to support GxP documentation and compliance within FDA-regulated environments. The role requires a Bachelor's degree in Computer Science with a minimum of three years of experience in validation. Strong knowledge in GAMP guidelines and a customer-first orientation are vital.

Preferred candidates should possess familiarity with Rockwell and DeltaV systems, and be skilled in handling documentation processes critical for operational readiness in the biotech and pharmaceutical industries.

Qualifications

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

Responsibilities

• Author GxP computer validation documentation.
• Support CSV activities across various platforms.
• Collaborate with client teams for validation compliance.

Skills

GxP computer validation documentation

Test protocols and scripts

Data integrity principles

Customer service orientation

Excellent communication skills

Education

Bachelor’s degree in Computer Science, Engineering

Tools

Rockwell PharmaSuite

DeltaV systems

Job description

Cagents based in Rockville, MD, seeks a Computer Systems Validation Specialist to support GxP documentation and compliance within FDA-regulated environments. The role requires a Bachelor's degree in Computer Science with a minimum of three years of experience in validation. Strong knowledge in GAMP guidelines and a customer-first orientation are vital.

Preferred candidates should possess familiarity with Rockwell and DeltaV systems, and be skilled in handling documentation processes critical for operational readiness in the biotech and pharmaceutical industries.