Lead Validation & Compliance Engineer

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

Benefits offered by this job

Medical, dental, and vision plans

Company-provided life and AD&D

Short and long-term disability

Retirement plan with employer match

Wellness programs

Employee assistance program

Commuter benefits

Parental leaves

Job summary

bioMérieux is seeking a Validation Specialist II in Illinois to develop and implement robust validation programs for processes, equipment, software, and cleaning systems. You will lead qualification efforts (IQ/OQ/PQ) and drive validation documentation, risk assessments, and continuous state-of-validation across manufacturing and support operations.

The role requires a 2+ year track record in cGMP validation, strong regulatory knowledge (FDA, ISO 13485, 21 CFR Part 11), and collaboration across

Qualifications

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

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
• Lead IQ, OQ, PQ, and software validation activities and re-validation efforts.
• Prepare, review, and approve validation documents and risk assessments.
• Monitor validated systems and controlled environments for ongoing compliance.

Skills

Validation lifecycle

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Written and verbal communication

Project management

Microsoft Excel

Education

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

Tools

Microsoft Office

Job description

bioMérieux is seeking a Validation Specialist II in Illinois to develop and implement robust validation programs for processes, equipment, software, and cleaning systems. You will lead qualification efforts (IQ/OQ/PQ) and drive validation documentation, risk assessments, and continuous state-of-validation across manufacturing and support operations.

The role requires a 2+ year track record in cGMP validation, strong regulatory knowledge (FDA, ISO 13485, 21 CFR Part 11), and collaboration across