Senior Computer System Validation Engineer - Data Integrity

Veg Group; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Computer System Validation Engineer to execute periodic reviews for ~42 computerized systems supporting QC and QA operations. You will evaluate lifecycle status, data integrity, changes, incidents, security controls, and validation documentation.

Responsibilities include planning reviews, assessing cGMP compliance, authoring reports, and supporting audits. Collaboration with Quality, IT, and lab personnel is essential for maintaining validated systems.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline.
• Five or more years of computerized system validation experience in pharmaceutical or biotechnology operations.
• Strong knowledge of risk-based CSV, data integrity, ALCOA+ principles, 21 CFR Part 11, and applicable GAMP practices.
• Experience conducting computerized-system periodic reviews.
• Experience with laboratory or quality platforms such as LIMS, Maximo, TrackWise, PI Historian, RIM, QBMS, or comparable systems.
• Experience preparing audit-ready documentation in Kneat, CDOCs, or equivalent platforms.

Responsibilities

• Plan and execute computerized-system periodic reviews according to approved schedules and procedures.
• Review system validation and lifecycle documentation, including intended use, configuration, validation plans, and reporting.
• Assess continued compliance with cGMP, data-integrity, and electronic-record requirements.
• Document validated-state conclusions, risks, recommendations, and remediation.
• Author and route periodic-review reports, validation assessments, and supporting documents.
• Support deviations, CAPAs, change controls, and investigations involving computerized systems.
• Collaborate with system owners, Quality, IT, Automation, and validation SMEs.
• Provide system documentation and SME support during audits and inspections.
• Maintain the review schedule, trackers, metrics, and status reports.

Skills

CSV knowledge

GxP awareness

Audits & inspections

Documentation skills

Cross-functional collaboration

Education

Bachelor’s degree (Engineering/CS/IS/Life Sciences)

Tools

LIMS

Maximo

TrackWise

PI Historian

RIM

QBMS

Kneat/CDOCs

Job description

Validation & Engineering Group, Inc. seeks a Computer System Validation Engineer to execute periodic reviews for ~42 computerized systems supporting QC and QA operations. You will evaluate lifecycle status, data integrity, changes, incidents, security controls, and validation documentation.

Responsibilities include planning reviews, assessing cGMP compliance, authoring reports, and supporting audits. Collaboration with Quality, IT, and lab personnel is essential for maintaining validated systems.