LL01-120425 CSV Specialist

Validation & Engineering Group•Clayton, NC

35d

About The Position

Validation & Engineering Group, Inc. (V&EG) 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.

Requirements

Bachelors degree in Engineering, IT, Computer Science, Life Sciences, or related field.
37+ 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: DeltaV , Syncade , Siemens PCS 7 , Siemens Desigo CC , OSI PI
Knowledge of: 21 CFR Part 11 , Annex 11 GAMP 5 Data Integrity Expectations (ALCOA+)
Basic understanding of automation architectures and IT infrastructure
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.

Responsibilities

Plan and execute validation activities for system upgrades, patches, new deployments, and configuration enhancements
Develop and maintain CSV documentation including: Validation Plans Risk Assessments (FMEA/Part 11/Data Integrity) 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.
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.
Work closely with vendors and automation SMEs to understand system changes for: DeltaV process control system upgrades and configuration changes Syncade MES recipe, workflow, and unit procedure modifications Siemens PCS 7 process automation enhancements Siemens Desigo CC BMS/BAS upgrades for facilities and cleanrooms 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.
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.