What are the responsibilities and job description for the Need USC/GC Only :: CSV / Validation Specialist – BMS position at Ampstek?
Job Title : CSV / Validation Specialist – BMS
Location : Lebanon, Indiana
Duration: Contract
Job Description ::
• 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, 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.
• 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.