Validation Specialist II — Impactful Compliance & QMS Lead

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

Benefits offered by this job

Medical plans

Life insurance

Disability insurance

Retirement plan

Adoption assistance

Wellness programs

Employee Assistance Program

Commuter benefits

Discount programs

Parental leaves

Job summary

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

You will lead IQ/OQ/PQ activities, review protocols, risk assessments, and validation master plans, and monitor validated systems to ensure ongoing compliance with cGMP, FDA, and ISO 13485. Collaborative cross-functional work and audit readiness are integral to the role.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum of two years of validation experience in a cGMP-regulated manufacturing environment with hands-on validation activities and documentation development.

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
• Lead 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, and related documents.
• Monitor validated systems and controlled environments to ensure ongoing compliance and validation state.
• Investigate deviations and non-conformances, implementing corrective and preventive actions as required.
• Support change control and assess validation impact of modifications.
• Collaborate with Engineering, Manufacturing, QA, QC, suppliers, and project teams for project execution.
• Participate in audits and remediation activities; provide validation training and guidance.
• Ensure compliance with regulatory requirements, including cGMP, FDA, ISO 13485, 21 CFR Part 11, and GAMP.

Skills

Validation lifecycle

Regulatory compliance

cGMP knowledge

Analytical & problem-solving

Communication skills

Project management

Cross-functional collaboration

MS Office proficiency

Education

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

Job description

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

You will lead IQ/OQ/PQ activities, review protocols, risk assessments, and validation master plans, and monitor validated systems to ensure ongoing compliance with cGMP, FDA, and ISO 13485. Collaborative cross-functional work and audit readiness are integral to the role.