Process Validation Specialist
On-site · Boston, Massachusetts, United States or Caguas, Caguas, Puerto Rico
Job Summary
Process Validation Specialist responsible for planning, coordinating, and executing validation activities for parenteral and aseptic manufacturing processes, preparing validation protocols and reports, conducting Aseptic Process Validation (including Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization), performing work inside clean rooms in GMP-regulated settings, and collaborating with QA/QC, production, and engineering to meet timelines, address deviations, maintain records, and support continuous improvement in validation processes and compliance.
Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field
- Minimum of 5–10 years’ experience in validation activities in FDA-regulated environments, preferably in parenteral or aseptic manufacturing
- Strong experience in Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization (Smoke Tests)
- Experience writing protocols, validation reports, and executing procedures inside clean rooms
- Knowledge of GMP, FDA regulations, and quality systems
- Proficiency in English; additional language skills are a plus
- Strong analytical, organizational, and problem-solving skills
- Excellent communication skills and ability to collaborate effectively across multidisciplinary teams
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