Senior CSV Validation Specialist (Building Management Systems)

Senior CSV Validation Specialist (Building Management Systems)

Location: Indianapolis, IN (100% Onsite)

Duration: Long Term

Job Overview

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.