LLCSV Specialist

Position: LL01-120425 CSV Specialist

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Computerized Systems Validation (CSV) Specialist – for IT/Automation System Upgrades Position Summary

The CSV Specialist will support computerized system upgrades and lifecycle validation activities for manufacturing automation, MES, building management, and data historian platforms in a regulated biopharmaceutical environment. The role ensures that all IT/Automation systems remain compliant with cGMP, 21 CFR Part 11, GAMP 5, and applicable data integrity requirements throughout design, configuration, testing, and deployment.

This individual will collaborate with IT, Automation, Quality, and Engineering teams to develop validation documentation, manage test execution, and ensure systems are released for GMP use in a timely and controlled manner.

Key Responsibilities CSV & Compliance

Plan and execute validation activities for system upgrades, patches, new deployments, and configuration enhancements.

Develop and maintain CSV documentation including:

• Validation Plans
• User Requirements (URS), Functional Specs (FS)
• Traceability Matrices
• Test Protocols (IQ/OQ/PQ), Data Integrity Assessments
• Validation Summary Reports (VSR)

Apply GAMP 5 and data integrity principles (ALCOA+) in all validation deliverables.

Ensure compliance with 21 CFR Part 11 and Annex 11 requirements.

Testing & HP ALM Administration

Execute and document qualification testing in HP ALM (required).

Track test progress, deviations, and defects within ALM workflows.

Partner with Quality to review and close discrepancies and change controls.

Support periodic review and re-validation strategies for CSV‑maintained systems.

Technical & System Focus

Work closely with vendors and automation SMEs to understand system changes for:

• Delta
  
  V – process control system upgrades and configuration changes
• Syncade MES – recipe, workflow, and unit procedure modifications
• Siemens Desigo CC – BMS/BAS upgrades for facilities and clean rooms
• Aveva OSI PI – historian infrastructure and data model improvements

Assess GMP impact for new functionality, system patches, and cybersecurity upgrades.

Support backup/restore testing, system hardening, and validated state lifecycle maintenance.

Project Support

Participate in project planning, FAT/SAT testing, and system handovers.

Provide CSV input to change control, risk assessments, and configuration documentation.

Contribute to schedule updates and progress reports with cross‑functional team leads.

Qualifications Education

Bachelor’s degree in Engineering, IT, Computer Science, Life Sciences, or related field.

Experience

3–7+ years in CSV within regulated (GMP) environments.

Hands‑on validation experience with HP ALM.

Experience supporting upgrades or implementations of one or more of the following:

Knowledge of:

• 21 CFR Part 11, Annex 11
• GAMP 5
• Data Integrity Expectations (ALCOA+)
• Basic understanding of automation architectures and IT infrastructure

Soft Skills

Strong organizational skills and attention to detail.

Excellent communication and document writing abilities.

Ability to interpret technical information and translate it into compliant documentation.

Comfortable working in a fast‑paced project environment with multiple priorities.

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