Senior Validation Specialist: cGMP & Compliance

bioMérieux; Lombard (IL); On-site; USD 91,000 - 117,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Retirement Plan

Wellness Programs

Employee Assistance

Commuter Benefits

Job summary

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across equipment, processes, software, and environments in Illinois. The role plans and executes validation activities, supports continuous improvement, and partners with multiple functions to sustain a validated state throughout manufacturing and support operations.

The successful candidate will have at least two years of cGMP validation experience, strong regulatory knowledge, and the

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 with hands-on validation activities.
• 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 technical documentation.
• Monitor validated systems and controlled environments to ensure ongoing compliance and validation maintenance.
• Investigate deviations and CAPAs related to validation and implement corrective actions.
• Support change control activities and assess validation impact from modifications.
• Collaborate with Engineering, Manufacturing, QA, QC, suppliers, and project teams for project execution.
• Participate in internal, external, and supplier audits and remediation activities.
• Provide training and guidance on validation requirements and best practices.
• Ensure compliance with cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.

Skills

Analytical skills

Problem-solving

Project management

Communication skills

Cross-functional collaboration

Education

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

Tools

Microsoft Office

MS Excel

Job description

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across equipment, processes, software, and environments in Illinois. The role plans and executes validation activities, supports continuous improvement, and partners with multiple functions to sustain a validated state throughout manufacturing and support operations.

The successful candidate will have at least two years of cGMP validation experience, strong regulatory knowledge, and the