Sr Engineer FM Technical Documentation and SAP specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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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

• Bachelors degree in a technical scientific or quality-related field (e.g. Engineering Life Sciences Technical Communication Quality Management).

Experience

• 35 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.

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