Validation Lead: Equipment, Software & Processes

BioFire Diagnostics, LLC; Lombard, Northern (IL, KY); Hybrid; USD 91,000 - 117,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Life and AD&D Insurance

Disability Insurance

Retirement Plan with employer match

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Parental leaves

Job summary

bioMérieux in Illinois seeks a Validation Specialist II to develop, implement, and maintain validation programs for equipment, processes, software, and cleaning systems. The role involves planning validation activities, supporting audits, and collaborating across functions to maintain validated state across operations.

The ideal candidate brings 2+ years in a cGMP environment, strong regulatory knowledge, and excellent analytical and communication skills.

Qualifications

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

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
• Lead IQ, OQ, PQ and software validation efforts, re-qualification and re-validation.
• Prepare, review, and approve validation protocols, reports, risk assessments, master plans, and documentation.
• Monitor validated systems to ensure ongoing compliance and state-of-validation maintenance.
• Investigate deviations and CAPAs related to validation and implement corrective actions.
• Support change control and assess validation impact of modifications.
• Collaborate with Engineering, Manufacturing, QA/QC, suppliers, and project teams for project execution.
• Participate in audits and remediation activities at internal, external, and supplier levels.
• Provide training on validation requirements, standards, and best practices.
• Ensure compliance with cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP.

Skills

Validation lifecycle

Regulatory compliance

Analytical skills

Communication

Project management

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Bachelor's degree in Biomedical Sciences

Tools

Microsoft Office

Excel

Word

Outlook

Teams

Job description

bioMérieux in Illinois seeks a Validation Specialist II to develop, implement, and maintain validation programs for equipment, processes, software, and cleaning systems. The role involves planning validation activities, supporting audits, and collaborating across functions to maintain validated state across operations.

The ideal candidate brings 2+ years in a cGMP environment, strong regulatory knowledge, and excellent analytical and communication skills.