Computer system validation expertise meets GCP compliance at Alimentiv, supporting reliable technology in a regulated clinical research workplace. This is a 12-month limited-term assignment.
As a Computer System Validation Specialist, you will validate GCP-regulated systems and software for Alimentiv. The work covers GxP, 21 CFR Part 11, quality systems, and validation documentation. You will collaborate with IT, Quality Assurance, business stakeholders, and external vendors to support compliant project delivery.
Key Responsibilities:
Execute validation activities for computerized systems and software
Develop plans, test scripts, matrices, reports, and release documentation
Coordinate validation testing and document requirements coverage
Manage defects, deviations, incidents,
and closure documentation
Guide change management for validated systems and regulatory updates
Requirements:
Bachelor's degree or equivalent education and experience
Three to five years of relevant experience
Experience validating GCP-regulated systems in regulated industries
Understanding of validation, documentation, change control, and audit readiness
Robust communication and cross-functional collaboration skills
Apply computer system validation, GCP compliance, and documentation expertise to support Alimentiv’s regulated technology workplace.