Job Title: Siemens BMS Assessment and Validation Consultant
Location: Indianapolis, IN / Hybrid
Key Responsibilities:
Conduct a comprehensive assessment of existing Siemens BMS validation documentation for Suites II and III. Develop and deliver a Gap Assessment Report, identifying nonconformities and opportunities for improvement relative to Suite I and FDA 21 CFR Part 11 compliance.
Prepare a detailed Validation Plan to remediate gaps, aligned with client validation policies and ISPE GAMP 5 guidelines.
Review and evaluate system lifecycle deliverables, including URS, FRS, RTM, Design Specs, IQ/OQ/PQ protocols, and validation reports.
Collaborate with internal Quality, Engineering, and Automation teams to ensure consistent validation approaches across all suites.
Participate in project onboarding and discovery sessions to understand client documentation practices, systems architecture, and operational requirements.
Provide technical input and recommendations on validation documentation templates, test strategies, and remediation procedures.
Support system revalidation or change control activities to bring BMS into full compliance.
Ensure all validation documentation complies with FDA, EU Annex 11, and GAMP 5 expectations for computerized systems.
Deliverables:
Current State Assessment Report for BMS validation documentation (Suites II & III)
Gap Assessment Report identifying deficiencies relative to Suite I and applicable regulatory standards
Remediation & Validation Plan with prioritized actions and timelines
Updated validation document templates (if applicable)
Final presentation of findings and remediation strategy to client leadership
Required Experience & Qualifications :
8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or medical device industry
Proven experience validating Building Management Systems (BMS) or Environmental Monitoring Systems (EMS) - Siemens BMS experience strongly preferred
Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and data integrity requirements
Demonstrated experience conducting validation assessments and gap analyses for automated or facility control systems
Hands-on experience developing:
Validation Plans
Risk Assessments
IQ/OQ/PQ protocols
Final validation reports
Strong analytical, documentation, and communication skills
Ability to work cross-functionally with QA, Engineering, and Regulatory teams
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
Preferred Qualifications:
Experience validating Siemens Desigo CC or Apogee BMS platforms
Prior involvement in remediation projects or multi-suite validation harmonization initiatives
Familiarity with GxP manufacturing environments, including aseptic or radiopharmaceutical operations
Prior consulting experience supporting clients during CSV audits or regulatory inspections
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