Sr Validation Specialist


Boca Raton
Permanent
USD120000 - USD140000
Quality
PR/597245_1781635297
Sr Validation Specialist

We're working with a growing pharmaceutical manufacturer building out their sterile manufacturing operations in South Florida. This team is expanding its validation function and looking for a hands-on Validation Engineer to support a live GMP environment producing injectable products.

This is a high-impact role where you'll be directly involved in validation activities across the manufacturing floor, working closely with quality and operations as the site continues to scale.

What you'll be doing:

  • Execute and support process, cleaning, and equipment validations in a GMP environment
  • Contribute to the development and execution of validation protocols (IQ/OQ/PQ)
  • Support filling line validation, including work around aseptic processing environments
  • Participate in validation lifecycle activities, including deviations, investigations, and change control
  • Assist with updates and maintenance of the Validation Master Plan (VMP)
  • Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams
  • Support readiness efforts for future regulatory inspections

What we're looking for:

  • ~5-8 years of experience in validation within a GMP-regulated industry
  • Hands-on experience with process, cleaning, or equipment validation
  • Exposure to pharmaceutical manufacturing environments (sterile or non-sterile)
  • Experience supporting or executing IQ/OQ/PQ protocols
  • Strong understanding of GMP compliance and documentation practices

Nice to have:

  • Experience in sterile or aseptic manufacturing environments
  • Exposure to filling lines, isolators, or lyophilization (freeze drying)
  • Experience working in or preparing for regulated inspections (FDA)

Additional details:

  • Location: Boca Raton, FL
  • Schedule: Fully onsite, 5 days per week
  • Compensation: Competitive base salary + bonus (aligned with market for validation professionals)
  • Open to candidates currently based in the US and eligible to work, including H1B transfers

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