Senior Validation Specialist: cGMP & Compliance Lead

bioMerieux; Bolingbrook (IL); Presencial; USD 91.000 - 117.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Life Insurance

Disability Insurance

Retirement plan

Adoption assistance

Wellness programs

Employee assistance

Commuter benefits

Discount programs

Parental leave

Descripción de la vacante

bioMérieux in Illinois is seeking a Validation Specialist II to develop, implement, and maintain validation programs for manufacturing processes, equipment, software systems, and cleaning and environmental controls.

The role plans and executes validation activities, supports continuous improvement, and collaborates cross-functionally to maintain a validated state across operations, with exposure to audits and regulatory compliance including cGMP and FDA requirements.

Formación

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

Responsabilidades

• 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 efforts.
• Prepare, review, and approve validation protocols, reports, risk assessments, validation master plans, technical documentation, and supporting records.
• Monitor validated systems and controlled environments to ensure ongoing compliance and state-of-validation maintenance.
• Investigate deviations, non-conformances, and validation-related issues, implementing corrective and preventive actions as required.
• Support change control activities and assess validation impact related to equipment, process, facility, or software modifications.
• Partner with Engineering, Manufacturing, Quality Assurance, Quality Control, suppliers, and project teams to ensure successful project execution.
• Participate in internal, external, and supplier audits, supporting audit readiness and remediation activities.
• Provide training and guidance on validation requirements, standards, and best practices.
• Ensure compliance with applicable regulatory requirements, including cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.

Conocimientos

Validation lifecycle

Regulatory compliance

cGMP knowledge

Analytical skills

Communication skills

Project management

Cross-functional collaboration

MS Office proficiency

IQ/OQ/PQ

Educación

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

Herramientas

IQ/OQ/PQ

Descripción del empleo

bioMérieux in Illinois is seeking a Validation Specialist II to develop, implement, and maintain validation programs for manufacturing processes, equipment, software systems, and cleaning and environmental controls.

The role plans and executes validation activities, supports continuous improvement, and collaborates cross-functionally to maintain a validated state across operations, with exposure to audits and regulatory compliance including cGMP and FDA requirements.