Validation Specialist II: Drive Compliance & Growth

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

Benefits offered by this job

Medical and dental plans

Vision plans

Life insurance

Disability insurance

Retirement plan

Parental leaves

Commuter benefits

Job summary

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software, and cleaning systems to stay compliant with cGMP, ISO 13485, FDA 21 CFR Part 11 and GAMP guidelines.

The role plans and executes validation activities, leads IQ/OQ/PQ, supports continuous improvement, and collaborates cross-functionally with Engineering, Manufacturing, Quality Assurance, and suppliers to maintain a validated state

Qualifications

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

Responsibilities

• Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.

Skills

Validation lifecycle

Regulatory compliance

Analytical skills

Problem-solving

Organizational skills

Communication skills

Multi-project management

Stakeholder management

Education

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

Tools

Microsoft Office

Job description

bioMérieux is seeking a Validation Specialist II to develop, implement, and maintain validation programs across manufacturing processes, equipment, software, and cleaning systems to stay compliant with cGMP, ISO 13485, FDA 21 CFR Part 11 and GAMP guidelines.

The role plans and executes validation activities, leads IQ/OQ/PQ, supports continuous improvement, and collaborates cross-functionally with Engineering, Manufacturing, Quality Assurance, and suppliers to maintain a validated state