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- 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 DeltaV 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.