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Validation Specialist

  • March 4, 2026
  • Category:
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Job Duties:

  • Authored and executed C&Q protocols, and C&Q documentation (URS, risk assessments, RTM, DQ) in compliance with regulations.
  • Verification of Drawings, P&ID walkdowns, component verification, turnover documentation verification.
  • Start-Up Support; Developed and/or updated SOPs, Work Instructions, Change controls, training material, review and drafting PMs, spare parts, and bill of materials documentation.
  • Drafted SOPs for operation and maintenance of HVAC and electrical equipment for critical utilities.
  • Initiated and closed change controls
  • Utilized Veeva software, Kneat, Smartsheets, Sharepoint, and MS Office Suite.
  • Authored plans for Asset Management and Preventive Maintenance of critical utilities equipment like TOC-Analyzers, pressure safety regulators, pumps, diaphragm and other safety valves on SAP.
  • Supported capital projects by participating in setting equipment criteria and specifications to analyze system reliability.
  • Coordinated with production to complete equipment repairs, and PM’s during opportunistic and scheduled downtime events
  • Ensure full compliance with FDA regulations, GAMP, and 21 CFR Part 11 standards across all validation and commissioning activities.
  • Use skills including: QMS (TrackWise, VeevaVault), Kneat, Valgenesis, Good Documentation Practices, ALCOA++, ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 11, OSHA – 29 CFR 1910, ASME, ANSI, ASTM E2500, cGMP, GAMP, Lean Six Sigma Principles, Continuous Improvement, Measurement System Analysis, Statistical Process Control, Hazard and Risk Analysis (Fault Tree Analysis, FMEA).

 

Requirements: 

Education: Master of Science degree in Industrial Technology, or Industrial Engineering.

 

Experience:

  • One year of experience in validating manufacturing equipment used in the medical device industry to ensure compliance with regulatory and quality standards;
  • One year of experience in utilizing methodologies including Failure Mode and Effects Analysis (FMEA), Gap Analysis, and Change Control;

 

Skills and knowledge: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.