Computer System Validation Coordinator

Inizio Engage XD • Yardley, PA

426d

About The Position

The Computer System Validation (CSV) Coordinator at Inizio Engage is responsible for generating and executing CSV protocols and reports in compliance with GxP standards, industry best practices, and company policies. This role also involves acting as the test lead for non-GxP systems, preparing necessary test protocols and reports, and supporting various audits and inspections as a CSV subject matter expert.

Requirements

• Bachelor's Degree or related work experience.
• 1-3 years of experience in a direct CSV role.
• 2 years of experience in a regulated environment.
• Working knowledge in creating test protocols for Salesforce in a regulated environment.
• Experience delivering CSV projects within the healthcare industry.
• Experience working with a structured Project Management Office (PMO).
• Good knowledge of GAMP, Annex 11, and 21CFR Part 11.
• Experience with Pharmaceutical Quality Systems including change control, deviation, CAPAs, and document management.

Nice To Haves

• Experience with Microsoft Visio and/or Adobe Acrobat.
• Project management and process design experience.

Responsibilities

• Generate and execute validation protocols and reports.
• Support IT COE with assessment of new global IT projects to ensure GxP requirements are understood.
• Manage the testing process for cloud-based platforms and report progress to project leads and CSV Lead.
• Support client audits, internal audits, and regulatory inspections as a CSV subject matter expert.
• Safeguard patient privacy and confidentiality in accordance with HIPAA guidelines.
• Perform other duties as assigned.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• 401(k)
• Parental leave
• Vision insurance
• Employee discount
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree