Validation Specialist
Validation Specialist / Validation Engineer
Boca Raton, FL | Sterile Injectable Pharmaceutical Manufacturing | Onsite
A growing pharmaceutical manufacturer is seeking a Validation Specialist / Validation Engineer to support qualification, validation, and lifecycle management activities across a sterile injectable manufacturing facility.
This individual will play a key role in ensuring manufacturing equipment, utilities, facilities, processes, and systems remain compliant with cGMP and regulatory requirements while supporting ongoing site growth and operational readiness.
Key Responsibilities
- Execute and maintain qualification and validation programs across manufacturing, utilities, facilities, and laboratory systems
- Author, review, and execute validation protocols, reports, and associated documentation
- Support equipment qualification activities including IQ, OQ, PQ, and requalification programs
- Perform validation activities for manufacturing equipment, process systems, and utility systems
- Support process validation, media fills, and cleaning validation programs
- Conduct risk assessments and validation impact assessments related to change controls
- Investigate validation-related deviations and implement corrective actions
- Review validation data and prepare summary reports
- Maintain validation schedules and support ongoing compliance activities
- Partner closely with Engineering, Manufacturing, Quality, Microbiology, and Quality Control teams
- Support internal audits, customer audits, and regulatory inspections
- Ensure validation documentation remains inspection-ready and compliant with cGMP requirements
Qualifications
- Bachelor's degree in Engineering, Chemistry, Pharmacy, Biotechnology, Microbiology, Life Sciences, or a related discipline
- 5+ years of validation experience within pharmaceutical manufacturing
- Experience supporting GMP-regulated manufacturing facilities
- Hands-on experience executing IQ/OQ/PQ activities
- Strong technical writing and documentation skills
- Experience supporting investigations, deviations, and change controls
- Strong understanding of validation lifecycle principles and regulatory expectations
- Excellent communication and cross-functional collaboration skills
Preferred
- Sterile injectable manufacturing experience
- Process validation experience
- Equipment qualification experience
- Utility qualification experience (WFI, Purified Water, HVAC, Clean Steam, Compressed Air)
- Cleaning validation experience
- Media fill support experience
- Knowledge of FDA regulations, cGMP, Annex 1, and Data Integrity requirements
- Experience supporting regulatory inspections and audit readiness initiatives
Ideal Background
- Validation Specialist
- Validation Engineer
- Senior Validation Specialist
- Commissioning & Qualification (CQV) Engineer
- Process Validation Engineer
- Equipment Validation Engineer
- Qualification Engineer
- Validation Scientist
- Manufacturing Validation Specialist
This opportunity is ideal for a validation professional looking to make a significant impact within a growing sterile pharmaceutical manufacturing environment while supporting critical compliance, quality, and operational initiatives.
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