Automation Specialist

Johnson & Johnson Co.; Leiden; Sur place; EUR 45 000 - 71 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical thinking

Technical problem-solving

Planning

Prioritization

Independence

English proficiency

Formation

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

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s What You Can Expect

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

#Hybrid

Preferred Skills

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

The Anticipated Base Pay Range For This Position Is

€44,700.00 - €70,840.00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.