Automation CSV Engineer

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.

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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 escalate 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.

Required Skills:

Preferred Skills:

The anticipated pay range for this position, in the primary posting location, is:

The anticipated pay ranges for additional locations are:

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.