Senior CSV Validation Specialist (Building Management Systems)

We are seeking an experienced Senior CSV Validation Specialist to support Building Management System (BMS) validation within a regulated pharmaceutical manufacturing environment. This role will lead the full Computer System Validation (CSV) lifecycle, ensuring compliance with FDA, EMA, and GAMP 5 requirements while partnering with Automation, IT, Engineering, and System Integrators., * Lead end-to-end validation of Building Management Systems (BMS) from URS through Validation Summary Reports.

• Author and execute validation documentation including URS, DQ, IQ, OQ, PQ, RTM, Validation Plans, and VSRs.
• Review software requirements and collaborate with vendors, including Johnson Controls, on system validation activities.
• Perform 21 CFR Part 11 assessments for electronic records, audit trails, and electronic signatures.
• Validate integrations between Metasys, AVEVA PI, DeltaV, and OPC UA platforms.
• Support commissioning, qualification, system acceptance testing, and periodic reviews.
• Develop SOPs and maintain validation documentation in an inspection-ready state.
• Support audit readiness, data integrity initiatives, remediation activities, and future system upgrades.
• Collaborate with Automation, IT, Engineering, Quality, and Validation teams to ensure GMP compliance.

• Strong experience in Computer System Validation (CSV) within pharmaceutical or GMP-regulated environments.
• Hands-on experience validating Building Management Systems (BMS) or industrial control systems.
• In-depth knowledge of GAMP 5, V-Model lifecycle, and risk-based validation methodologies.
• Experience with 21 CFR Part 11 compliance and computerized system validation.
• Proven experience authoring and executing CSV documentation, including URS, FS, DS, IQ, OQ, PQ, RTM, Validation Plans, and Validation Summary Reports.
• Experience supporting BMS, DCS, PLC, HMI, or Historian systems.
• Strong understanding of FDA and EMA regulatory requirements.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you. Please follow Stark Pharma Solutions on LinkedIn for the latest job updates