Validation Engineer

Katalyst Healthcares & Life Sciences

Boulder, CO
30+ days ago

Highlights

We are seeking an experienced Validation Engineer with strong hands-on experience qualifying and validating pharmaceutical manufacturing equipment, specifically automated Parts Washers. Evaluate critical parameters including wash/rinse temperature, cycle time, detergent concentration, spray pressure/coverage, loading configurations, and drying parameters.

Numbers & Facts

Location

Boulder, CO

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.

Validation Engineer

Katalyst Healthcares & Life Sciences

Highlights

Numbers & Facts

Description

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