Validation Engineer

Creative Solutions Services, LLC; Boulder (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC in Boulder, CO seeks an experienced Validation Engineer to qualify pharmaceutical manufacturing equipment, focusing on automated Parts Washers, in a fast-paced production environment.

You will develop IQ/OQ/PQ protocols, support FAT/SAT and commissioning, review critical documents, and help ensure strict adherence to cGMP/FDA requirements at a live site.

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.
• 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.

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.

Skills

IQ/OQ/PQ experience

FAT/SAT experience

GMP/cGMP knowledge

Independent on-site work

Parts Washer qualification

CAPA/deviation handling

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry, or related field

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.