Validation Specialist II: cGMP & ISO Compliance

bioMerieux; Downers Grove (IL); On-site; USD 91,000 - 117,000; Full time

Benefits offered by this job

Medical plans

Dental plan

Vision plan

Life insurance

Job summary

bioMérieux, a leader in in vitro diagnostics, seeks a Validation Specialist II to develop and maintain comprehensive validation programs across equipment, processes and software. This role drives IQ/OQ/PQ activities, risk assessments, and documentation to sustain cGMP-compliant validated states within manufacturing and support operations.

The successful candidate will collaborate with Engineering, Manufacturing, QA/QC, and suppliers to ensure continuous improvement, audit readiness, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum of two years of validation experience in a cGMP manufacturing environment with hands-on IQ/OQ/PQ, process, software, environmental, or cleaning validation.
• 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.
• 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 and validation-related issues, implementing corrective and preventive actions as required.

Skills

Validation lifecycle

Regulatory compliance

Documentation

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Engineering/Life Sciences/Biomedical Sciences

Tools

Microsoft Office

Excel

Word

Outlook

Teams

Job description

bioMérieux, a leader in in vitro diagnostics, seeks a Validation Specialist II to develop and maintain comprehensive validation programs across equipment, processes and software. This role drives IQ/OQ/PQ activities, risk assessments, and documentation to sustain cGMP-compliant validated states within manufacturing and support operations.

The successful candidate will collaborate with Engineering, Manufacturing, QA/QC, and suppliers to ensure continuous improvement, audit readiness, and