Automation Data Integrity Lead - Validation & Compliance

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine seeks an Automation Data Integrity Lead to strengthen data integrity across automation platforms at our Leiden site. You will guide validation planning, implement risk-based decisions and drive compliance with EU GMP Annex 11 and 21 CFR Part 11 through practical tool use and stakeholder collaboration.

You will lead planning, prioritization and alignment with QA Validation, site and global teams, while promoting a culture of quality and accountability across

Qualifications

• 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.

Responsibilities

• Plan and prioritize Data Integrity and validation activities across Automation per global standards.
• Apply Data Integrity principles and risk-based thinking during project planning and scoping.
• Support Kneat and other validation tools across teams, aligning with system owners.
• Participate in data integrity assessments, risk assessments and design reviews; track actions and close gaps.
• Maintain relationships with QA Validation, site and global Data Integrity, and system owners.
• Build stakeholder support for new standards, training and buddy programs with SMEs.
• Assist audit readiness, including EU GMP Annex 11 topics, coordinating commitments and inspections.
• Promote a culture of quality, ownership and early risk escalation within the team.

Skills

Data Integrity

Validation

Kneat

Risk Assessments

Stakeholder Mgmt

Project Planning

Cross-functional

Quality Assurance

English Proficiency

Change Management

Education

Bachelor's or Master's in Engineering/Life Sciences

Tools

Kneat

Job description

Johnson & Johnson Innovative Medicine seeks an Automation Data Integrity Lead to strengthen data integrity across automation platforms at our Leiden site. You will guide validation planning, implement risk-based decisions and drive compliance with EU GMP Annex 11 and 21 CFR Part 11 through practical tool use and stakeholder collaboration.

You will lead planning, prioritization and alignment with QA Validation, site and global teams, while promoting a culture of quality and accountability across