Automation Specialist

Biopharma Careers; Leiden; Remote; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (12 weeks)

Well-being reimbursement

Health insurance

Job summary

Johnson & Johnson Innovative Medicine seeks an Automation Specialist to support QC laboratories, lead automation projects, and maintain computerized systems ensuring data integrity and GMP compliance. You will drive LEAN improvements across the team and collaborate with multiple departments to ensure product quality.

The role requires a strong background in life sciences, GMP, and software validation, with good English and Dutch language skills preferred. Leiden-based, full-time position.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent with strong GMP knowledge.
• Experience with validated computerized systems in a GxP environment is required.
• 2+ years in pharma QA/QC or automation roles is preferred.

Responsibilities

• Lead the technical implementation of new laboratory systems with cross-functional teams.
• Create and maintain installation, validation, and maintenance procedures.
• Provide timely support and troubleshoot issues involving computerized systems.
• Ensure compliance with 21 CFR Part 11 requirements for all systems.
• Drive investigations into non-conformances involving systems and materials.
• Coordinate corrections and preventive actions with follow-up validation.

Skills

Analytical Reasoning

Data Analysis

Compliance Management

Continuous Improvement

Quality Control (QC)

Quality Standards

ISO 9001

Lab Automation

Education

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

Tools

Computerized system validation tools

Job description

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

About Innovative Medicine

Ourexpertisein 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.

Required Skills:

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

Preferred Skills:

• Analytical Reasoning
• Business Behavior
• Compliance Management
• Continuous Improvement
• Controls Compliance
• Data Analysis
• Execution Focus
• ISO 9001
• 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:

• 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.
• 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
• 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.