Validation Specialist II - GMP & Regulatory Compliance

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

Benefits offered by this job

Medical/Dental/Vision plans

Retirement Plan with employer match

Life Insurance

Job summary

bioMérieux seeks a Validation Specialist II in Illinois to develop, implement, and maintain validation programs across manufacturing, equipment, software, and cleaning processes.

You will lead IQ/OQ/PQ activities, prepare validation documents, and drive continuous improvement with cross-functional teams while ensuring regulatory compliance (FDA, cGMP, ISO 13485). Travel may be required.

Eligible for a variable annual bonus as part of bioMérieux's Total Rewards package.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum of two years in validation within a cGMP manufacturing environment with hands-on validation activities and 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 equipment, process, facility, or software modifications.
• Partner with Engineering, Manufacturing, QA/QC, suppliers, and project teams to ensure successful project execution.
• Participate in internal, external, and supplier audits, supporting audit readiness and remediation activities.
• Provide training and guidance on validation requirements, standards, and best practices.
• Ensure compliance with regulatory requirements including cGMP, FDA, ISO 13485, 21 CFR Part 11, and GAMP.

Skills

Validation lifecycle

cGMP

Regulatory standards

Analytical skills

Communication skills

Cross-functional

Project management

MS Office

Problem-solving

Education

Bachelor's degree (Engineering/Life Sciences)

Job description

bioMérieux seeks a Validation Specialist II in Illinois to develop, implement, and maintain validation programs across manufacturing, equipment, software, and cleaning processes.

You will lead IQ/OQ/PQ activities, prepare validation documents, and drive continuous improvement with cross-functional teams while ensuring regulatory compliance (FDA, cGMP, ISO 13485). Travel may be required.

Eligible for a variable annual bonus as part of bioMérieux's Total Rewards package.