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Senior Validation Engineer
Senior Validation EngineerTundra Technical Solutions • Athens, GA, United States
Senior Validation Engineer

Senior Validation Engineer

Tundra Technical Solutions • Athens, GA, United States
[job_card.variable_hours_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

We’re seeking an experienced Validation professional to independently lead and execute complex validation activities supporting GMP manufacturing operations. This role is ideal for a hands-on, compliance-focused expert who can balance multiple priorities, lead validation efforts with minimal oversight, and partner cross-functionally to support equipment readiness, inspections, and new product launches.

Key Responsibilities

Validation Leadership & Execution

  • Independently draft, execute, and close validation plans, protocols, test strategies, and final reports
  • Lead qualification activities for equipment, facilities, utilities, and computerized systems
  • Serve as Lead Validation representative on project teams supporting changes, deviations, tech transfers, and new product launches
  • Ensure validation activities meet GMP, FDA, EU, and internal quality requirements
  • Maintain validation areas in a constant state of inspection readiness

Technical & Cross-Functional Support

  • Partner with Engineering, Maintenance, Production, and Quality teams on system selection, upgrades, and commissioning
  • Develop and review URS, RA, FRS, and DQ documentation
  • Support cleaning validation, utilities qualification (HVAC, water, gases), and media fill oversight
  • Execute requalification and periodic reviews for autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas
  • Perform room qualifications and smoke studies in Grade A pharmaceutical environments

    • Compliance, Audits & Continuous Improvement

  • Support Change Controls, Deviations, and CAPAs, ensuring on-time closure
  • Assist with audit responses and regulatory inspections
  • Train personnel on validation and quality principles
  • Monitor and support completion of required compliance training and KPIs

    • Required Experience

  • 6+ years of GMP validation experience in a regulated manufacturing environment
  • (10+ years accepted in lieu of a degree)
  • At least 3 years leading validation projects
  • Strong experience with :
  • Equipment, facilities, utilities, and computer system validation
  • Cleaning validation concepts
  • Pharma-grade utilities (HVAC, water, gases)
  • Ellab data loggers and software
  • Extensive technical writing experience with minimal reviewer oversight
  • Ability to analyze validation and production data to assess GMP compliance
  • Strong leadership, planning, and cross-functional collaboration skills
  • Excellent written and verbal communication skills
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint

    • Education

  • Bachelor’s degree preferred (Science or Engineering discipline)

    • Why This Role

  • High-visibility validation ownership with real operational impact
  • Opportunity to lead complex projects in a regulated biopharmaceutical environment
  • Strong cross-functional exposure across Engineering, Production, and Quality
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