Automation CSV Engineer

Johnson Johnson; Leiden; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Johnson & Johnson's Leiden site seeks an Automation Data Integrity Lead to strengthen data integrity across automation systems. You will lead planning, validation improvements and stakeholder engagement to ensure robust data governance and compliance with EU GMP Annex 11.

You will guide the implementation of digital validation tools like Kneat, coordinate risk assessments, and partner with QA Validation, site DI, CQ&A, and system owners to drive continuous quality improvements.

Qualifications

• 5+ years of hands-on automation experience in a GMP-regulated environment.
• Experience with computerized system validation and Data Integrity (EU GMP Annex 11, 21 CFR Part 11).
• Proven experience leading Data Integrity assessments, risk assessments, process mapping and design reviews.
• Hands-on experience with Kneat or other digital validation tools.
• Strong planning, milestone setting and cross-functional coordination skills.
• Excellent English communication; Dutch is a plus.

Responsibilities

• Plan and prioritize Data Integrity and validation improvements across Automation per J&J standards.
• Apply Data Integrity principles during project planning and scoping to embed compliance.
• Lead adoption of Kneat and ensure consistent use across teams.
• Coordinate Data Integrity assessments, risk mappings and design reviews with stakeholders.
• Maintain alignment with QA Validation, site DI, CQ&A and system owners.
• Support audits and inspections, including EU GMP Annex 11 topics; assist in readiness.

Skills

Automation experience

Stakeholder management

Communication skills

Cross-functional collaboration

Education

Bachelor's or master's degree in engineering, life sciences, IT or related field

Tools

Kneat

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 .

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

Supply Chain Engineering

Job Sub Function

Automation Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Leiden, South Holland, Netherlands

Job Description

Automation Data Integrity Lead

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 searching for the best talent for Automation Data Integrity Lead.

Purpose: Our Leiden site is on a journey to strengthen quality, compliance and data integrity across systems and processes. This role will focus on building lasting capability Automation needs to apply, govern and sustain Data Integrity and validation improvements beyond individual projects.

You will lead planning, prioritization, stakeholder engagement and alignment with other areas of the business. You'll bring practical knowledge of Data Integrity, risk-based validation and digital validation tools to everyday decisions. You'll ensure changes are understood, supported and built into Automation ways of working.

You will be responsible for:

• Planning and prioritizing Data Integrity and validation process improvement activities across Automation according to J&J Global standards.


• Applying Data Integrity principles, risk-based thinking and validation requirements during project planning and scoping, so compliance considerations are found early and built into delivery plans.


• Guiding the adoption of Kneat and other digital validation tools in practice. You'll support their use across teams, align with system owners and help teams apply them consistently.


• Taking part in Data Integrity assessments, data process flow mapping, risk assessments and design reviews, with a focus on coordinating actions, following up with action owners and closing gaps.


• Owning relationships with Quality Assurance Validation, site and global Data Integrity, Commissioning & Qualification, and system owners, so priorities, standards and timelines stay aligned.


• Building stakeholder support for new standards, training and peer-to-peer or buddy programs, working with the subject matter experts who lead execution.


• Supporting audit and inspection readiness, including EU GMP Annex 11 topics, by coordinating preparation, tracking commitments and representing Automation in inspections when needed.


• Be a presence in the team that reinforces a culture of quality, ownership and accountability. Promoting transparency and early escalation of risks.

Qualifications / Requirements

• Bachelor's or master's degree in engineering, life sciences, information technology or a related field.


• 5+ years of experience with deep hands-on experience in automation or computerized systems in a GMP-regulated environment.


• Practical experience with computerized system validation and Data Integrity principles, including EU GMP Annex 11 and 21 CFR Part 11 expectations.


• Proven experience leading Data Integrity assessments, risk assessments, data process mapping and design reviews.


• Hands-on experience with electronic validation tools, preferably Kneat, including configuration, templates and execution standards.


• Proven ability to plan and coordinate cross-functional work, set milestones, track progress and escalating risks early.


• Strong stakeholder management skills, with the ability to influence without authority and build trusted relationships across Quality, Engineering and Operations.


• Excellent communication skills in English. Dutch is an advantage.


• Change management experience or certification is a plus.

#LI-Hybrid

#LI-Hybrid

Preferred Skills

• Analytical Reasoning, Artificial Intelligence (AI), Controls Compliance, Cross-Functional Collaboration, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math