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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