Validation Specialist II — cGMP Compliance

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

Benefits offered by this job

Medical plan

Dental and vision plans

Life Insurance

Disability insurance

Retirement plan with employer match

Job summary

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software systems, and cleaning processes. The role ensures ongoing compliance with cGMP, FDA 21 CFR Part 11, ISO 13485, and related standards.

You will lead IQ/OQ/PQ activities, generate validation master plans and documentation, and collaborate with Engineering, Manufacturing, QA, and suppliers to drive project success and a state of validation

Qualifications

• Bachelor's degree required in engineering, life sciences, or biomedical sciences.
• Minimum two years in validation within a cGMP manufacturing environment.
• Experience developing validation docs, protocols, and risk assessments.

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning, and environmental controls.
• Lead IQ/OQ/PQ, process validation, and software validation activities.
• Prepare, review, and approve validation docs and risk assessments.
• Monitor systems and environments for ongoing compliance.
• Investigate deviations and implement CAPAs as needed.
• Support change control and assess validation impact of modifications.
• Collaborate with engineering, manufacturing, QA, and suppliers.
• Participate in audits and drive remediation.

Skills

Validation lifecycle

Regulatory compliance

cGMP knowledge

Quality documentation

Cross-functional collaboration

Analytical skills

MS Office

Education

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

Tools

Excel

Word

Outlook

Teams

Job description

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software systems, and cleaning processes. The role ensures ongoing compliance with cGMP, FDA 21 CFR Part 11, ISO 13485, and related standards.

You will lead IQ/OQ/PQ activities, generate validation master plans and documentation, and collaborate with Engineering, Manufacturing, QA, and suppliers to drive project success and a state of validation