Validation Engineer — Med Devices & Pharmaceuticals

SOLVENTUM; New York (NY); On-site; USD 106,000 - 146,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care FSA

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences and Retirement Benefits

Relocation Assistance

Job summary

Solventum in Columbia, MO is seeking a Validation Engineer to ensure manufacturing processes for medical devices and drugs meet regulatory standards. You will validate new and existing processes, develop validation protocols, and maintain compliant documentation.

The role requires a BS/BA in science or engineering and 5 years in validation/engineering within regulated industries, with travel up to 10% and onsite work in Columbia, MO.

Qualifications

• Bachelor’s degree and five years of validation/engineering experience in pharma/medical devices/biotech.
• Experience applying cGMP, FDA 21 CFR Parts 210/211, 820, 11, and related regulations.
• Lean Six Sigma certification and cross‑functional project involvement preferred.

Responsibilities

• Train and mentor manufacturing and quality teams on validation processes and regulations.
• Develop, plan, and execute IQ/OQ/PQ validation activities for devices and drugs.
• Create and maintain validation documentation and ensure GMP/FDA compliance.
• Collaborate with R&D, Manufacturing, QA, IT, and Regulatory Affairs on product introductions and changes.
• Support audits/inspections and coordinate re‑validation activities as needed.

Skills

Validation

cGMP

Regulatory knowledge

Cross-functional teamwork

Process validation

Education

Bachelor’s degree or higher in science/engineering

Job description

Solventum in Columbia, MO is seeking a Validation Engineer to ensure manufacturing processes for medical devices and drugs meet regulatory standards. You will validate new and existing processes, develop validation protocols, and maintain compliant documentation.

The role requires a BS/BA in science or engineering and 5 years in validation/engineering within regulated industries, with travel up to 10% and onsite work in Columbia, MO.