Automation Specialist

Johnson & Johnson; Netherlands; On-site; EUR 65,000 - 90,000; Full time

Job summary

360Pharma is seeking an experienced Automation Specialist with a strong interest in analytical methods and computerized systems to support our QC laboratories. As the Subject Matter Expert for automation, you will support data integrity, the implementation and maintenance of computerized systems, and laboratory robotics.

You will help ensure GMP compliance and contribute to LEAN improvements across the team and its processes.

Qualifications

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience.
• Basic understanding of GMP regulations, 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 experience; laboratory exposure is a plus.
• Experience with computerized system validation in a GxP environment.

Responsibilities

• Lead the technical implementation of new laboratory systems with cross-functional teams.
• Create and maintain installation, maintenance, and procedural documentation.
• Provide timely support and troubleshoot issues involving computerized systems.
• Ensure equipment implementations comply with 21 CFR Part 11 requirements.
• Contribute to laboratory system initiatives and projects across the global organization.

Skills

Analytical Reasoning

Data Analysis

Problem Solving

Planning

Prioritization

Communication

Quality awareness

Education

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

Tools

GxP systems

Computerized systems

Job description

We are looking for an experienced Automation Specialist with a strong interest in analytical methods and computerized systems to support our QC laboratories. As the Subject Matter Expert for automation, you will support data integrity, the implementation and maintenance of computerized systems, and laboratory robotics. You will help ensure GMP compliance and contribute to LEAN improvements across the team and its processes.

Your primary responsibility will be to perform, document, and manage investigations related to quality records. You will identify root causes and define and implement corrective actions.

The NC Automation Specialist should have a strong background in quality control, quality assurance, or a related pharmaceutical field. The role requires close collaboration across departments to maintain product quality and compliance.

Key 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.

Required qualifications

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience in a similar role.
• Good knowledge of relevant local and global procedures, with a basic understanding 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.

Preferred Skills

• Analytical Reasoning
• Business Behavior
• Compliance Management
• Continuous Improvement
• Controls Compliance
• Data AnalysisExecution Focus
• ISO 9001
• Persistence and Tenacity
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Report Writing
• Sample Testing
• Technologically Savvy