CSV Validation Lead for GxP Systems

JobDiva, Inc.; Cambridge (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

JobDiva, Inc. seeks a Computer Systems Validation Engineer to validate GxP computer systems, both on‑premises and cloud-based, ensuring compliance with industry standards. You will draft docs, perform risk assessments, and manage validation lifecycles.

You will lead CSV/CSA guidance, develop harmonized procedures, and generate lifecycle artifacts (URS, IQ/OQ/PQ, RTM) while assessing new systems for impact and balancing compliance with efficiency.

Qualifications

• Bachelor's degree in Engineering, Computer Science or related discipline.
• 3–5+ years of CSV experience in an FDA regulated industry.
• Strong knowledge of cGMP and FDA 21 CFR Part 11 and EU Annex 11.
• Understanding of data integrity requirements and assessments.
• Experience qualifying on premises and cloud-based software systems.
• Ability to influence stakeholders on CSV, CSA and GxP compliance.
• Experience managing complex validation projects and timelines.
• Knowledge of quality systems such as change control and discrepancy investigations.
• Experience with IT qualification of network and infrastructure.
• Demonstrated written and verbal communication skills.

Responsibilities

• Provide CSV and CSA compliance guidance to IT, system owners, and stakeholders.
• Lead development and adherence to CSV/CSA procedures with risk-based validation.
• Generate and execute lifecycle deliverables per GAMP 5 (URS, SRS, FRS, DDS, RTM, IQ/OQ/PQ).
• Assess proposed systems for GxP impact and define CSA validation strategy.
• Review vendor documentation and perform independent risk-based verification.
• Support change control, deviation resolution, CAPA and effectiveness checks.
• Manage decommissioning of retired systems.
• Ensure supplier controls and risk-based oversight of IT services.

Skills

CSV compliance

Regulatory knowledge

Risk-based methodology

Documentation

Validation lifecycle

Vendor management

cGMP knowledge

FDA 21 CFR Part 11

Communication skills

Mentoring

Education

Bachelor's degree in Engineering/Computer Science or related discipline

Tools

LabWare LIMS

MasterControl

SAP

Blue Mountain

EMS

IT infrastructure

Job description

JobDiva, Inc. seeks a Computer Systems Validation Engineer to validate GxP computer systems, both on‑premises and cloud-based, ensuring compliance with industry standards. You will draft docs, perform risk assessments, and manage validation lifecycles.

You will lead CSV/CSA guidance, develop harmonized procedures, and generate lifecycle artifacts (URS, IQ/OQ/PQ, RTM) while assessing new systems for impact and balancing compliance with efficiency.