Senior CSV Validation Lead - GMP BMS Specialist

Stark Pharma Solutions Inc; Indianapolis (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Senior CSV Validation Specialist to lead Building Management System validation in a regulated pharmaceutical manufacturing environment on a 100% onsite basis in Indianapolis.

You will own the CSV lifecycle, ensure compliance with FDA, EMA and GAMP 5, collaborate with Automation, IT, Engineering, Quality and Validation teams, and produce URS, IQ, OQ, PQ, RTM and VSR documentation while maintaining inspection-ready records.

Qualifications

• Extensive CSV experience in pharma or GMP environments.
• Hands-on validation of 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 ability to author and execute CSV documentation (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.

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.

Skills

CSV validation

GMP environment

GAMP 5

21 CFR Part 11

URS/IQ/OQ/PQ/RTM

BMS/industrial control systems

Regulatory knowledge (FDA/EMA)

Tools

Metasys

AVEVA PI

DeltaV

OPC UA

Job description

Stark Pharma Solutions Inc. is seeking a Senior CSV Validation Specialist to lead Building Management System validation in a regulated pharmaceutical manufacturing environment on a 100% onsite basis in Indianapolis.

You will own the CSV lifecycle, ensure compliance with FDA, EMA and GAMP 5, collaborate with Automation, IT, Engineering, Quality and Validation teams, and produce URS, IQ, OQ, PQ, RTM and VSR documentation while maintaining inspection-ready records.