Senior Validation Specialist: cGMP & Compliance

bioMerieux Inc.; Lombard (IL); On-site; USD 91,000 - 117,000; Full time

Benefits offered by this job

Healthcare plans

Life insurance

Disability insurance

Retirement plan

Adoption assistance

Wellness program

Employee assistance program

Commuter benefits

Various voluntary benefits

Discount programs

Job summary

bioMerieux Inc. in Illinois is seeking a Validation Specialist II to develop, implement, and maintain comprehensive validation programs for equipment, processes, software, and environmental controls.

The role ensures cGMP compliance and ongoing state‑of‑validation across manufacturing and support operations. Responsibilities include leading IQ/OQ/PQ activities, preparing validation documents, monitoring systems, and driving continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or Biomedical Sciences required.
• Minimum of two years of validation experience in a cGMP‑regulated manufacturing environment with hands‑on experience in equipment, process, software, environmental, or cleaning validation activities.
• Experience developing validation documentation, protocols, reports, and risk assessments.

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
• Lead qualification and validation activities, including IQ, OQ, PQ, process validation, software validation, re‑qualification, and re‑validation efforts.
• Prepare, review, and approve validation protocols, reports, risk assessments, validation master plans, technical documentation, and supporting records.
• Monitor validated systems and controlled environments to ensure ongoing compliance and state‑of‑validation maintenance.
• Investigate deviations, non‑conformances, and validation‑related issues, implementing corrective and preventive actions as required.
• Support change control activities and assess validation impact related to modifications.
• Partner with Engineering, Manufacturing, QA, QC, suppliers, and project teams for project execution.
• Participate in audits and remediation activities; provide training on validation requirements and best practices.

Skills

Validation lifecycle

cGMP compliance

Regulatory knowledge

Analytical skills

Communication

Education

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

Tools

Excel

Word

Outlook

Teams

Job description

bioMerieux Inc. in Illinois is seeking a Validation Specialist II to develop, implement, and maintain comprehensive validation programs for equipment, processes, software, and environmental controls.

The role ensures cGMP compliance and ongoing state‑of‑validation across manufacturing and support operations. Responsibilities include leading IQ/OQ/PQ activities, preparing validation documents, monitoring systems, and driving continuous improvement.