QC Automation Specialist – GMP & Lab Systems

Johnson & Johnson Co.; Leiden; On-site; EUR 60,000 - 90,000; Full time

Job summary

Johnson & Johnson Leiden is seeking an experienced Automation Specialist for its QC laboratories. You will support data integrity, implement and maintain computerized systems, and drive LEAN improvements while ensuring GMP compliance.

The role centers on investigations of quality records and collaboration across departments. You will lead technical projects, validate systems in a GxP environment, and act as SME during inspections, contributing to global initiatives and continuous improvement in

Qualifications

• Bachelor's degree (HBO) in Life Sciences, Computer Science, or equivalent experience in a similar role.
• Good knowledge of GMP regulations, FDA and EMA guidelines, and quality-control and compliance best practices.
• At least two years of experience in the pharmaceutical industry, including GMP and automation responsibilities.
• Hands-on experience in software development and programming. Laboratory experience is an advantage.
• Experience with computerized system validation in a GxP environment.
• Strong analytical, technical problem-solving, planning, and prioritization skills.
• Proven ability to build productive relationships at all levels of the organization.
• Excellent written and spoken English; Dutch is desirable.
• Proactive and able to work independently, take initiative, and prepare protocols, reports, and procedures.

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 collaboration with the global organization and in line with business needs.
• Support the team in resolving day-to-day technical challenges.
• Lead or support investigations into non-conformances involving systems, testing of raw materials, in-process materials, drug substance and drug product, and related processes.
• Define, coordinate, and implement corrections, corrective and preventive actions, and effectiveness checks.
• Act as a Subject Matter Expert and participate in inspections when required.

Skills

Analytical

Problem-solving

Planning

Prioritization

English proficiency

Communication

Independence

Education

Bachelor's degree (HBO) in Life Sciences or Computer Science

Job description

Johnson & Johnson Leiden is seeking an experienced Automation Specialist for its QC laboratories. You will support data integrity, implement and maintain computerized systems, and drive LEAN improvements while ensuring GMP compliance.

The role centers on investigations of quality records and collaboration across departments. You will lead technical projects, validate systems in a GxP environment, and act as SME during inspections, contributing to global initiatives and continuous improvement in