Job Description

*No C2C

*Must be a US Citizen or Permanent Resident

The GxP / Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments comply with applicable GxP regulations (e.g., GMP, GCP, GLP) and industry standards. This role leads and supports validation activities throughout the system lifecycle, ensuring systems are fit for intended use and maintained in a validated state.

Key Responsibilities

Validation & Compliance

• Plan, execute, and document CSV activities in accordance with GxP regulations, FDA guidance, EMA guidelines, and industry standards (e.g., GAMP 5).
• Develop and review validation deliverables including:
• Validation Plans (VP)
• User Requirements Specifications (URS)
• Functional / Design Specifications (FS/DS)
• Risk Assessments
• IQ/OQ/PQ protocols and reports
• Traceability Matrices
• Ensure computerized systems remain in a validated state through effective change control, deviation management, and periodic review.

System Lifecycle Support

• Support validation activities across the full system lifecycle (concept, implementation, operation, and retirement).
• Assess the impact of system changes, upgrades, patches, and configuration changes on validation status.
• Perform vendor assessments and support supplier audits as required.

Quality & Audit Support

• Ensure compliance with data integrity principles (ALCOA+).
• Participate in internal audits, regulatory inspections, and customer audits.
• Respond to audit findings and support CAPA development and execution.

Cross-Functional Collaboration

• Collaborate with IT, Quality Assurance, Engineering, Manufacturing, Clinical, and external vendors.
• Provide CSV guidance and training to stakeholders.
• Act as a subject matter expert for CSV and GxP computerized systems.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 3+ years of experience in GxP Computer System Validation in a regulated environment.
• Strong knowledge of:
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data Integrity principles
• Experience validating systems such as:
• ERP (e.g., SAP)
• LIMS, MES, QMS
• Clinical Trial Management Systems (CTMS)
• Laboratory or manufacturing equipment with software components
• Excellent documentation, analytical, and communication skills.

Preferred Qualifications

• Experience with cloud-based and SaaS systems validation.
• Familiarity with Agile or SDLC methodologies in regulated environments.
• Experience supporting FDA, EMA, or other regulatory inspections.
• CSV certification or quality-related certifications (e.g., ASQ, ISPE).

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