Automation Specialist

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

Benefits offered by this job

Annual bonus

Vacation & parental leave

Well-being programs

Insurance plans

Recognition awards

Job summary

Johnson & Johnson in the Netherlands is seeking an experienced Automation Specialist for QC laboratories. You will support data integrity, the validation of computerized systems, and LEAN improvements while ensuring GMP compliance.

You will perform investigations into quality records, define CAPAs, and collaborate with cross-functional groups to sustain product quality and regulatory adherence, including 21 CFR Part 11. English is essential; Dutch desirable.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• GMP knowledge and familiarity with FDA/EMA guidelines.
• 2+ years in pharmaceutical industry with GMP and automation experience.
• Hands-on software development experience and programming.
• GxP computerized system validation experience.
• Strong analytical and problem-solving skills; effective planning.
• Excellent English; Dutch desirable.
• Ability to build relationships across levels of the organization.

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 with the global organization and business needs.
• Support the team in resolving day-to-day technical challenges.
• Lead or support investigations into non-conformances involving systems and materials.
• Define, coordinate, and implement corrective/preventive actions and effectiveness checks.
• Act as a Subject Matter Expert and participate in inspections when required.

Skills

GMP knowledge

FDA/EMA guidelines

Pharma experience

Software development

Laboratory experience

Computerized system validation

Analytical skills

Problem solving

Planning

Prioritization

Stakeholder management

English proficiency

Dutch desirable

Analytical reasoning

Compliance management

Continuous improvement

Quality systems documentation

Data analysis

ISO 9001

Quality control

Report writing

Sample testing

Technologically savvy

Education

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

Job description

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. 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.

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

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.

The anticipated base pay range for this position is: €44,700.00 - €70,840.00.

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 https://www.jnj.com/.