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Validation Engineer

Katalyst Healthcares & Life Sciences
  • Boulder, CO
  • Instant Apply
26 days ago

Job Description

Job Description:
We are seeking an experienced Validation Engineer with strong hands-on experience qualifying and validating pharmaceutical manufacturing equipment, specifically automated Parts Washers.
Key Responsibilities:
  • Execute validation and qualification activities for automated Parts Washers.
  • Develop, review, and execute IQ/OQ/PQ protocols and reports.
  • Support FAT/SAT, commissioning, and equipment qualification.
  • Review URS, FS, DS, P&IDs, equipment specifications, and related documentation.
  • Support Parts Washer cleaning-cycle development and qualification.
  • Evaluate critical parameters including wash/rinse temperature, cycle time, detergent concentration, spray pressure/coverage, loading configurations, and drying parameters.
  • Execute/support riboflavin spray coverage testing.
  • Support cleaning validation, including visual inspection, swab/rinse sampling, TOC, conductivity, and residue testing.
  • Identify worst-case loads/soils and support cleaning acceptance criteria.
  • Resolve deviations, discrepancies, change controls, and CAPAs.
  • Collaborate with QA, Engineering, Manufacturing, QC, and equipment vendors.
  • Ensure compliance with cGMP, FDA requirements, and site procedures.
  • Prepare clear, audit-ready validation documentation.
Required Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related field.
  • 5+ years of pharmaceutical/biopharmaceutical validation or CQV experience.
  • Hands-on Parts Washer qualification/validation experience is highly preferred and a key requirement.
  • Strong IQ/OQ/PQ and FAT/SAT experience.
  • GMP/cGMP pharmaceutical manufacturing experience.
  • Knowledge of cleaning validation and equipment qualification.
  • Experience with deviations, change controls, CAPAs, and validation documentation.
  • Ability to work independently at a manufacturing site.

Numbers & Facts

LocationBoulder, CO

Skills

  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Chemistryunmatched
  • Cleaning Equipmentunmatched
  • Commissioningunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • Equipment Specificationunmatched
  • Equipment Validationunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Equipmentunmatched
  • Process Validationunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Soil Mechanicsunmatched
  • Testingunmatched
  • Validation Documentationunmatched

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