Computer System Validation Engineer - Lifecycle & Data Integrity

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. in Juncos, PR is seeking a Computer System Validation Engineer to execute periodic reviews for about 42 computerized systems supporting QC and QA operations.

The role evaluates system lifecycle status, data integrity, changes, incidents, security controls, validation documentation, and continued fitness for intended use, and requires collaboration with Quality, IT, Automation, and lab personnel.

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 and current system configuration; Validation plans, requirements, specifications, testing, and reports; Change controls, incidents, deviations, CAPAs, and problem records; User access, security roles, and periodic-access reviews; Audit trails and data-integrity controls; Backup, restoration, archival, and business-continuity controls; Software upgrades, patches, interfaces, and infrastructure changes; Vendor support and system-obsolescence status; Open validation actions and previous periodic-review commitments.
• Assess continued compliance with applicable cGMP, data-integrity, and electronic-record requirements.
• Document validated-state conclusions, risks, recommendations, and required 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, laboratory personnel, and validation SMEs.
• Provide computerized-system documentation and SME support during audits and inspections.
• Maintain the computerized-system review schedule, trackers, metrics, and status reports.

Skills

CSV (computerized system validation)

Risk-based validation

ALCOA+ data integrity

21 CFR Part 11 compliance

GAMP practices

Audit-ready documentation

Collaborative QA/IT

Education

Bachelor's degree in Engineering / Computer Science / Information Systems / Life Sciences

Tools

LIMS

Maximo

TrackWise

PI Historian

RIM

QBMS

Kneat / CDOCs

Job description

Validation & Engineering Group, Inc. in Juncos, PR is seeking a Computer System Validation Engineer to execute periodic reviews for about 42 computerized systems supporting QC and QA operations.

The role evaluates system lifecycle status, data integrity, changes, incidents, security controls, validation documentation, and continued fitness for intended use, and requires collaboration with Quality, IT, Automation, and lab personnel.