Senior Validation Specialist- BMS

Lebanon, IN, US • Posted 1 day ago • Updated 1 day ago
Contract W2
Contract Independent
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • GAMP 5
  • BMS
  • DCS
  • PLC/HMI

Summary

  • 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10319975
  • Position Id: 8950056
  • Posted 1 day ago
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