Validation Specialist II - cGMP & Regulatory Excellence

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

Benefits offered by this job

Medical, dental, vision plans

Retirement plan with company match

Wellness programs

Commuter benefits

Adoption assistance

Job summary

bioMérieux in Illinois is seeking a Validation Specialist II to develop, implement, and maintain validation programs for equipment, processes, software, environmental controls, and cleaning systems. You will plan and execute validation activities, support continuous improvement, and collaborate cross-functionally to keep operations in a validated state.

The role requires hands-on experience with validation documentation, protocols, reports, and risk assessments, and a strong understanding of

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum of two years in validation within a cGMP manufacturing environment.
• Experience with validation documentation, protocols, reports and risk assessments.

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, and environmental controls.
• Lead IQ/OQ/PQ, process and software validation, re-qualification, and re-validation efforts.
• Prepare, review, and approve validation protocols, reports, and risk assessments.
• Monitor validated systems and environments to ensure ongoing compliance.
• Investigate deviations and CAPA, supporting change control activities.
• Collaborate with Engineering, Manufacturing, QA/QC, suppliers and project teams.
• Participate in audits and provide training on validation requirements.

Skills

Validation lifecycle

Regulatory compliance

Analytical skills

Problem solving

Organizational skills

Written communication

Verbal communication

Cross-functional collaboration

Project management

Education

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

Tools

Excel

Word

Teams

Job description

bioMérieux in Illinois is seeking a Validation Specialist II to develop, implement, and maintain validation programs for equipment, processes, software, environmental controls, and cleaning systems. You will plan and execute validation activities, support continuous improvement, and collaborate cross-functionally to keep operations in a validated state.

The role requires hands-on experience with validation documentation, protocols, reports, and risk assessments, and a strong understanding of