Senior Validation Specialist - Equipment, Software & Processes

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

Benefits offered by this job

Medical plan

Life insurance

Disability insurance

Retirement plan

Adoption assistance

Wellness programs

Commuter benefits

Voluntary benefits

Job summary

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

You will lead IQ/OQ/PQ activities, review validation documentation, investigate deviations, and collaborate with Engineering, QA, and Manufacturing to ensure ongoing state-of-validation and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
• Minimum two years of validation experience in a cGMP manufacturing environment with IQ/OQ/PQ, process, software, environmental or cleaning validation.
• 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 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 documentation.
• Monitor validated systems and controlled environments to ensure ongoing compliance.

Skills

Analytical thinking

Communication

Project management

Cross-functional collaboration

Problem solving

Education

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

Tools

Microsoft Office

Job description

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

You will lead IQ/OQ/PQ activities, review validation documentation, investigate deviations, and collaborate with Engineering, QA, and Manufacturing to ensure ongoing state-of-validation and regulatory compliance.