Validation Specialist II — cGMP Compliance & Validation

bioMerieux; Des Plaines (IL); On-site; USD 91,000 - 117,000; Full time

Benefits offered by this job

Medical plans (PPO/HDHP)

Life Insurance

Short and Long-Term Disability

Retirement Plan

Commuter Benefits

Adoption Assistance

Wellness Programs

Employee Assistance Program

Job summary

bioMérieux seeks a Validation Specialist II to develop and maintain validation programs ensuring compliant processes, equipment, software, and environments in our Illinois manufacturing operations. You will plan, execute, and lead validation activities while supporting continuous improvement and cross‑functional collaboration.

The role requires a Bachelor's in a related field and at least two years of cGMP validation experience, with strong documentation and problem‑solving skills.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum two years of validation experience in a cGMP environment; hands‑on validation activities and documentation.

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
• Lead IQ, OQ, PQ, process, software validation, re‑qualification, and re‑validation efforts.
• Prepare, review, and approve validation protocols, reports, risk assessments, and validation master plans.
• Monitor validated systems and environments to maintain ongoing compliance.
• Investigate deviations and CAPAs; support change control and validation impact assessments.
• Collaborate with Engineering, Manufacturing, QA, suppliers, and project teams on validation projects.

Skills

Validation lifecycle

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Project management

Problem solving

Microsoft Office

Education

Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences

Tools

Microsoft Office

Job description

bioMérieux seeks a Validation Specialist II to develop and maintain validation programs ensuring compliant processes, equipment, software, and environments in our Illinois manufacturing operations. You will plan, execute, and lead validation activities while supporting continuous improvement and cross‑functional collaboration.

The role requires a Bachelor's in a related field and at least two years of cGMP validation experience, with strong documentation and problem‑solving skills.