Validation Specialist II - Compliance & Process Improvement

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

Benefits offered by this job

Medical plans

Life Insurance

Disability Insurance

Retirement plan

Wellness programs

Commuter benefits

Parental leave

Job summary

bioMérieux in Illinois seeks a Validation Specialist II to develop and maintain validation programs ensuring manufacturing processes, equipment, software systems meet regulatory and company standards. The role plans and executes validation activities, supports continuous improvement, and collaborates cross-functionally to maintain a validated state across manufacturing and support operations.

Salary range estimates are provided with a bonus opportunity; bioMérieux offers comprehensive benefits

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum two years in validation within a cGMP manufacturing environment.

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, Quality Assurance, Quality Control, 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 applicable regulatory requirements, including cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.

Skills

Validation lifecycle

Regulatory compliance

Analytical skills

Communication skills

Project management

Education

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

Tools

Microsoft Excel

Microsoft Word

Outlook

Teams

Job description

bioMérieux in Illinois seeks a Validation Specialist II to develop and maintain validation programs ensuring manufacturing processes, equipment, software systems meet regulatory and company standards. The role plans and executes validation activities, supports continuous improvement, and collaborates cross-functionally to maintain a validated state across manufacturing and support operations.

Salary range estimates are provided with a bonus opportunity; bioMérieux offers comprehensive benefits