Automation Specialist, QC Systems Lead (Hybrid)

Johnson & Johnson Co.; Leiden; On-site; EUR 45,000 - 71,000; Full time

Job summary

Johnson & Johnson Leiden seeks an experienced Automation Specialist to support QC laboratories with strong automation expertise and data integrity focus. You will manage computerized systems, ensure GMP compliance, and drive LEAN improvements across the team and related processes.

Your role involves investigations of quality records, root-cause analysis, and implementing corrective actions while collaborating with multiple departments to uphold product quality and compliance.

Qualifications

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent.
• GMP knowledge and familiarity with FDA/EMA guidelines and quality-control best practices.
• At least two years in the pharmaceutical industry with GMP and automation responsibilities.
• Hands-on software development and programming experience; laboratory exposure is a plus.
• Experience with computerized system validation in a GxP environment.
• Strong analytical and problem-solving skills with planning and prioritization ability.
• Excellent written and spoken English; Dutch is desirable.

Responsibilities

• Lead the technical implementation of new laboratory systems with cross-functional teams.
• Create and maintain administrative, technical installation, and maintenance procedures.
• Provide timely support and troubleshoot issues involving computerized systems.
• Ensure equipment implementations comply with 21 CFR Part 11 requirements.
• Contribute to laboratory systems initiatives and projects in global alignment.
• Lead or support investigations into non-conformances involving systems and materials.
• Define, coordinate, and implement corrections, corrective and preventive actions, and effectiveness checks.

Skills

Analytical thinking

Technical problem-solving

Planning

Prioritization

Independence

English proficiency

Education

Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent

Job description

Johnson & Johnson Leiden seeks an experienced Automation Specialist to support QC laboratories with strong automation expertise and data integrity focus. You will manage computerized systems, ensure GMP compliance, and drive LEAN improvements across the team and related processes.

Your role involves investigations of quality records, root-cause analysis, and implementing corrective actions while collaborating with multiple departments to uphold product quality and compliance.