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 c

GMP, 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.