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Engineering Jobs in Miami, FL

Validation Engineer

Katalyst Healthcares & Life Sciences
  • Miami, FL
  • Instant Apply
30+ days ago

Job Description

Roles & Responsibilities: 
  • Execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment or processes.
  • Assist with writing and executing Commissioning, Qualification, and Validation (CQV) protocols supporting cGMP manufacturing, fill-finish operations, and QC laboratories.
  • Author acceptance reports and provide validation activity updates to project teams.
  • Support facility and utility expansions, compliance upgrades, process improvements, construction projects, and related initiatives.
  • Apply Good Documentation Practices, cGMP requirements, and current industry practices to equipment and systems validation.
  • Collaborate with Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control teams.
  • Review change controls, work orders, document change requests, and vendor-generated validation protocol packages.
  • Update applicable SOPs following completion of validation activities.
  • Support limited multi-shift operations, training, and testing as needed.
     
Required skills:
  • Minimum 3–5 years of experience in a sterile pharmaceutical and FDA-regulated industry.
  • Validation experience.
  • Sterile manufacturing experience.
  • Working knowledge of Microsoft Office applications.
  • Knowledge of cGMP requirements, Good Documentation Practices, and validation of manufacturing and laboratory equipment or processes.
  • Strong technical writing, communication, organization, and cross-functional collaboration skills.
  • Familiarity with equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, and aseptic processing areas.
    Education 
  • Associate of Science degree in a technical or scientific discipline required, or three years of related experience in lieu of a degree.
  • Bachelor of Science degree desired.
     
 

Numbers & Facts

LocationMiami, FL

Skills

  • Asepsisunmatched
  • Autoclaveunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Change Requests/Ordersunmatched
  • Commissioningunmatched
  • Construction Projectsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Documentationunmatched
  • Equipment Validationunmatched
  • FDA (Food and Drug Administration)unmatched
  • HVACunmatched
  • Laboratory Equipmentunmatched
  • Laboratory Operationsunmatched
  • Manufacturingunmatched
  • Microsoft Officeunmatched
  • Performance Analysisunmatched
  • Process Improvementunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Quality Engineeringunmatched
  • Reporting Skillsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • System Validationunmatched
  • Team Playerunmatched
  • Technical Writingunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched
  • Writing Skillsunmatched

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