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.
Is travel required for position?*
Yes – onsite daily
Project Location*
Lebanon, Indiana
Relevant Experience*
7-10 years
Mandatory skills*
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.
Desired skills*
Direct experience validating JCI Metasys, Honeywell, Siemens, or similar BMS platforms.
Experience with AVEVA PI Historian, DeltaV, 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, ValGenesis, or similar electronic validation management systems.
