Senior Validation Specialist II: GMP & Quality Impact

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

Benefits offered by this job

Medical plans

Retirement plan with employer match

Wellness programs

Commuter benefits

Parental leaves

Job summary

bioMérieux in Illinois seeks a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software, and cleaning systems. You will lead qualification efforts and ensure ongoing validation state across operations.

You will create and approve protocols, reports, and risk assessments while monitoring systems for continued compliance and leading cross-functional collaboration with Engineering, Manufacturing, QA, and suppliers.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences is required.
• Minimum of two years of validation experience in a cGMP manufacturing environment.
• 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.

Skills

Validation lifecycle

Regulatory compliance

Analytical skills

Communication skills

Project management

MS Office

Education

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

Tools

Excel

Word

Outlook

Teams

Job description

bioMérieux in Illinois seeks a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software, and cleaning systems. You will lead qualification efforts and ensure ongoing validation state across operations.

You will create and approve protocols, reports, and risk assessments while monitoring systems for continued compliance and leading cross-functional collaboration with Engineering, Manufacturing, QA, and suppliers.