Senior Validation Specialist – IQ/OQ/PQ Leader

bioMerieux; Addison (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

Job summary

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing, equipment, software, and cleaning processes. You will independently plan validation activities, support continuous improvement, and collaborate across Engineering, Manufacturing, QA, and project teams to sustain a validated state.

Responsibilities include leading IQ/OQ/PQ and re-validation efforts, preparing validation documentation, and ensuring compliance with cGMP,

Qualifications

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

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.
• Prepare, review, and approve validation protocols, reports, risk assessments, and validation master plans.

Skills

Validation lifecycle

Regulatory compliance

CGMP/FDA/ISO13485

Analytical skills

Communication

Project management

Cross-functional collaboration

MS Office

Education

Bachelor's degree

Tools

MS Office

Electronic QA systems

Job description

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing, equipment, software, and cleaning processes. You will independently plan validation activities, support continuous improvement, and collaborate across Engineering, Manufacturing, QA, and project teams to sustain a validated state.

Responsibilities include leading IQ/OQ/PQ and re-validation efforts, preparing validation documentation, and ensuring compliance with cGMP,