We are looking for a SME's to the  Itron AMI 2.0 Distributed Intelligence and integrating to the following:

• 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.

• Lead validation lifecycle activities for automation and control systems at LMF, including DeltaV, PI Historian, Rockwell PLC/HMI, and Metasys platforms.
• Develop and execute validation plans (VP), user requirement specifications (URS), functional specifications (FS), design specifications (DS), and configuration specifications (CS) for automation systems.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• 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 all in-scope automation systems.
• Conduct risk assessments (including GAMP 5 categorization and functional risk assessments) for automation and control system components.
• Manage validation change control by assessing the impact of system changes, patches, and upgrades on the validated state and determining revalidation requirements.
• Support periodic review activities to confirm that automation systems remain in a validated state and that validation documentation is current.
• Define and execute the CSV/validation scope for the ServiceNow platform in collaboration with the ServiceNow Process Owner.
• Validate system integrations between automation platforms and ServiceNow, including event connectors, CMDB connectors, API interfaces, and access provisioning workflows.
• Draft and maintain standard operating procedures (SOPs) related to computer systems validation for automation systems.
• 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 automation and historian systems.
• Assist with commissioning and qualification (C&Q) activities for new automation equipment.
• Support remediation of validation findings from internal audits or regulatory inspections.
• Advise on validation strategy for future automation system upgrades and expansions.

• Serve as the dedicated owner for ServiceNow module design, configuration, and governance across the Automation Department.
• Architect the CMDB structure for automation systems, define CI relationship models, and establish data quality standards.
• Design and configure Incident, Problem, Knowledge, and Change Management workflows.
• Establish integration architecture between ServiceNow and DeltaV, PI Historian, Rockwell, CyberArk/AD, and reporting platforms.
• Deploy automated access request forms and role-based permission workflows.
• Build analytics dashboards, KPI tracking, and SLA compliance reporting.
• Support GMP compliance, audit readiness, and 21 CFR Part 11 requirements within the ServiceNow platform.
• Collaborate with the CSV Engineer to ensure ServiceNow configurations are validated appropriately.
• Develop and deliver user training and change management communications.
• Support CMDB Data Steward activities including CI accuracy management, discovery reconciliation, and data quality scoring.
• Provide support defining the CSV/Validation scope for the ServiceNow platform.

- Role is an onsite-only Salesforce Admin/Manager who will oversee the current admin and report to the COO.

- Work hours 7:30am - 4:30pm Monday - Friday with Traditional Suit/Tie attire 

- Preferred background: financial services; 5–8 years' experience; 100% Salesforce proficiency required; certifications highly preferred.

- Technical stack: primary Salesforce; secondary HubSpot (marketing); traders use Orion; potential migration to Advisor360.

General experience and other details:

1.       Life Sciences-specific experience, including GxP processes, batch genealogy, clinical vs. commercial flows, quality release, and regulatory compliance.

2.      End-to-end solution architecture integrating to other modules

3.Experience in SAP, 2 SAP S/4 full life cycle programs experience and Min 1 project experience in tolling

4.      LS industry experience is MUST

5.      Start date: 1st wk of March’2026 with six months duration