CSV/Validation Specialist - BMS
Job in
Indianapolis, Marion County, Indiana, 46278, USA
Listed on 2026-06-01
Listing for:
Spruce Infotech
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
- Lead the BMS validation lifecycle across all 8 LMF buildings, from URS authoring through Validation Summary Report and closeout.
- Author and obtain approval for User Requirement Specifications (URS) for the Metasys BMS platform.
- Engage JCI on Software Requirement Specifications (SRS) review and acceptance.
- Develop and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Risk based approach adhering to Lilly Quality procedures.
- Generate and maintain requirements traceability matrices (RTMs) linking requirements through design, testing, and acceptance.
- Author Validation Summary Reports (VSR) documenting validation outcomes, deviations, and acceptance rationale.
- Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across Metasys and AVEVA PI.
- Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT cybersecurity validation (ISA/IEC 62443).
- Validate OPC/UA integration between Metasys, AVEVA PI, and Delta
V QBMS. - Draft commissioning protocols and support system acceptance testing.
- Draft and maintain SOPs related to BMS operations, operator training, and preventive maintenance.
- Enroll systems into the periodic review program for ongoing validated-state maintenance.
- Support audit readiness by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and Lilly corporate quality standards.
- Provide support for data integrity assessments across BMS and historian systems.
- Assist with commissioning and qualification (C&Q) activities for new BMS equipment.
- Support remediation of validation findings from internal audits or regulatory inspections.
- Advise on validation strategy for future BMS system upgrades and expansions.
- Demonstrated experience in computer systems validation (CSV) for building management or automation and control systems in a pharmaceutical/GMP-regulated environment.
- Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches.
- Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements.
- Proficiency in developing validation deliverables: VP, URS, FS, DS, IQ/OQ/PQ protocols, RTMs, and VSRs.
- Experience with BMS, DCS, PLC/HMI, or historian systems in a manufacturing environment.
- Strong understanding of FDA and EMA regulatory expectations for computerized system validation.
- Direct experience validating JCI Metasys, Honeywell, Siemens, or similar BMS platforms.
- Experience with AVEVA PI Historian, Delta
V, or OPC/UA integration validation. - Familiarity with ISA 18.2 alarm management and ISA/IEC 62443 cybersecurity standards.
- Familiarity with data integrity principles (ALCOA+) and data governance frameworks.
- Experience with Kneat, Val Genesis, or similar electronic validation management systems.
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