Validation Engineer – Med Devices & Pharma

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

Benefits offered by this job

Relocation Assistance

Competitive benefits

Job summary

Solventum is seeking a Validation Engineer onsite in Columbia, MO, to validate manufacturing processes for medical devices and drug products and ensure compliance with FDA, GMP, and ISO standards. You will develop validation protocols, coordinate IQ/OQ/PQ/PPQ activities, and collaborate across R&D, Manufacturing, QA, IT, and Regulatory Affairs.

The role requires a BS or higher in science/engineering and 5 years of validation/engineering experience in regulated industries; Lean Six Sigma

Qualifications

• Bachelor's degree or higher in a science or engineering discipline plus 5 years of validation/engineering experience.
• Experience applying cGMP and FDA/regulatory requirements in regulated environments.
• Experience with cross-functional teams and continuous improvement.
• Lean Six Sigma certification.
• Experience performing process and software validation for manufacturing equipment.

Responsibilities

• Provide training and mentorship on validation processes, regulations, and best practices.
• Develop, plan, support and execute IQ/OQ/PQ/PPQ validation activities for medical devices and drugs.
• Create and maintain validation documentation and ensure GMP/FDA/ISO compliance.
• Collaborate with Laboratory, Manufacturing, QA, IT, and Regulatory Affairs to support new products and process changes.
• Monitor validated processes and coordinate re-validation activities as needed.
• Support internal and external audits by preparing validation documentation and addressing audit findings related to validation.

Skills

Validation experience

Cross-functional collaboration

Regulatory compliance

Process validation

Education

Bachelor's degree or higher (Science/Engineering)

Job description

Solventum is seeking a Validation Engineer onsite in Columbia, MO, to validate manufacturing processes for medical devices and drug products and ensure compliance with FDA, GMP, and ISO standards. You will develop validation protocols, coordinate IQ/OQ/PQ/PPQ activities, and collaborate across R&D, Manufacturing, QA, IT, and Regulatory Affairs.

The role requires a BS or higher in science/engineering and 5 years of validation/engineering experience in regulated industries; Lean Six Sigma