Validation Engineer — GMP & Regulatory Validation for Med Devices

Solventum; Columbia Township (MO); On-site; USD 106,000 - 146,000; Full time

Job summary

Solventum in Columbia, MO is seeking a Validation Engineer to ensure manufacturing processes for medical devices and drug products meet regulatory standards. You will develop and execute IQ, OQ, PQ, and PPQ protocols, and maintain comprehensive validation documentation.

You will collaborate with R&D, Manufacturing, Quality Assurance and Regulatory Affairs, provide training on validation practices, and support audits and inspections.

Qualifications

• Bachelor's degree or higher in a science or engineering discipline and five years of validation/engineering experience in pharma/medical devices/biotech
• Experience applying cGMP, FDA 21 CFR Parts 210/211, 820, 11, EudraLex Vol. 4 in regulated environments
• Experience working with cross-functional teams to support validation, eng, quality, manufacturing, or operations
• Experience leading or participating in continuous improvement projects

Responsibilities

• Validate processes and equipment to ensure regulatory compliance and product quality
• Develop, plan, support and execute IQ/OQ/PM/PQ/PPQ validation activities
• Create and maintain validation documentation and reports, ensure GMP/FDA/ISO compliance
• Collaborate with Laboratory, Manufacturing, QA, IT, and Regulatory Affairs to support new products and changes

Skills

Validation engineering

cGMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation

Process validation

Software validation

IQ/OQ/PQ/PPQ

Lean Six Sigma

Education

Bachelor's degree in science/engineering

Job description

Solventum in Columbia, MO is seeking a Validation Engineer to ensure manufacturing processes for medical devices and drug products meet regulatory standards. You will develop and execute IQ, OQ, PQ, and PPQ protocols, and maintain comprehensive validation documentation.

You will collaborate with R&D, Manufacturing, Quality Assurance and Regulatory Affairs, provide training on validation practices, and support audits and inspections.