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**Job Function: **
Environmental Health, Safety (EH&S) and Facilities Services (FS)
**Job Sub Function: **
Facilities Management & Planning
Job Category:
Professional
All Job Posting Locations:
Leiden, South Holland, Netherlands
Job Description:
Job Summary
The Technical Documentation Specialist at Johnson & Johnson is responsible for the creation, management, and maintenance of compliant technical documentation across regulated products and systems. This role plays a critical part in ensuring documentation accuracy, consistency, and regulatory compliance throughout the product lifecycle, supporting quality, engineering, manufacturing, and regulatory functions.
The specialist works within a highly regulated pharma environment and ensures documentation aligns with global regulatory requirements, quality management systems, and J&J internal standards.
Secondly the job combines expertise on SAP / ERP on how we manage our equipment status, our master data and inventory management
You will work with a team of contractors that implement the changes to data and documentations initiated by projects.
Key Responsibilities
Documentation Development & Maintenance
- Author, review, and maintain high-quality technical documentation (e.g., PnID, SOPs, work instructions, technical files, validation documents).
- Ensure documentation is clear, accurate, and fit for purpose for internal and external stakeholders.
- Maintain document version control, traceability, and archival in approved document management systems.
- Ensure documentation associated with SAP-managed equipment and inventory data is accurate, traceable, and aligned with Quality System requirements.
Regulatory & Quality Compliance
- Ensure documentation complies with applicable regulations and standards, such as: FDA (21 CFR Parts 820, 11) EU MDR / IVDR ISO standards (e.g., ISO 13485, ISO 14971) GxP requirements where applicable
- Support internal and external audits, inspections, and regulatory submissions.
- Participate in change control and CAPA processes related to documentation.
Cross-Functional Collaboration
- Collaborate with Engineering, Quality Assurance, Regulatory Affairs, Manufacturing, R&D, and Supply Chain teams.
- Partner with Engineering, Manufacturing, Facilities, and Supply Chain teams to support SAP-based equipment, master data and inventory processes.
- Act as a Technical documentation subject-matter expert, advising teams on best practices and compliance requirements.
- Support global alignment of documentation across sites and regions.
Continuous Improvement
- Identify opportunities to improve documentation processes, templates, and tools.
- Support digitalization and standardization initiatives within documentation systems.
- Contribute to knowledge sharing and training related to documentation practices.
Required Qualifications
Education
- Bachelor’s degree in a technical, scientific, or quality-related field (e.g., Engineering, Life Sciences, Technical Communication, Quality Management).
Experience
- 3–5 years of experience in technical documentation within a regulated environment (medical devices, pharmaceuticals, biotech, or healthcare).
- Proven experience working with document management systems (e.g., TeDis, Meridian, or other). and with SAP.
- Familiarity with regulatory and quality system requirements.
Skills & Competencies
- Strong technical writing and editing skills.
- High attention to detail and accuracy.
- Solid understanding of documentation lifecycle management.
- Ability to work independently and manage multiple priorities.
- Strong communication and stakeholder management skills.
- Proficiency in Microsoft Office and documentation tools.
- Ability to translate work into clear packages to be executed by a well performing contractors team
Preferred Qualifications
- Experience within Johnson & Johnson or similar multinational healthcare organizations.
- Knowledge of EU MDR technical documentation structures.
- Experience supporting audits and regulatory inspections.
- Background in engineering, quality, or regulatory affairs.
Values & Behaviors
- Demonstrates commitment to J&J Credo values.
- Upholds integrity, compliance, and quality excellence.
- Embraces collaboration, diversity, and continuous improvement.
**Required Skills: **
Preferred Skills:
Access Control (AC), Business Behavior, Conflict Resolution, Data-Driven Decision Making, Disruptive Innovations, Facility Management, Facility Management Software, Organizing, Premises Management, Proactive Behavior, Problem Solving, Project Reporting, Security Planning, Service Excellence, Standard Operating Procedure (SOP), Subject Matter Experts (SME) Collaboration