Automation Specialist

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

Company Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

Our Values

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Professional

All Job Posting Locations

Leiden, South Holland, Netherlands

Job Description

About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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.
• Proactive and able to work independently, take initiative, and prepare protocols, reports, and procedures.