LLCSV Specialist

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.

• 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.
• 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 Delta
  
  V 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 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.

• 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.

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 :
  Delta
  
  V Syncade Siemens PCS 7 Siemens Desigo CC OSI PI

• 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.

IC