Validation Specialist II – GMP & Compliance Lead

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

Benefits offered by this job

Medical plans

Dental plans

Vision plans

Life Insurance

Disability Insurance

Retirement plan

Adoption assistance

Wellness programs

Employee assistance

Job summary

bioMérieux is seeking a Validation Specialist II in Illinois to develop, implement, and maintain validation programs across equipment, processes, software, and cleaning systems. The role plans and executes validation activities and collaborates with cross-functional teams to uphold validated states.

Responsibilities include creating protocols and reports, handling deviations, and supporting audits while ensuring compliance with cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum of two years of experience in validation within a cGMP-regulated manufacturing environment with hands‑on experience with equipment, process, software, environmental, or cleaning 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, 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

cGMP knowledge

Analytical skills

Problem solving

Communication skills

Project management

Education

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

Tools

Excel

Word

Outlook

Teams

Job description

bioMérieux is seeking a Validation Specialist II in Illinois to develop, implement, and maintain validation programs across equipment, processes, software, and cleaning systems. The role plans and executes validation activities and collaborates with cross-functional teams to uphold validated states.

Responsibilities include creating protocols and reports, handling deviations, and supporting audits while ensuring compliance with cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.