Documentation Specialist

Documentation Specialist

Location: Nijmegen

Working mode: On-site/Hybrid, minimum 3 days per week on-site

Duration: Contract running until end of September 2026 (project based role)

Hours: Full-time hours, 40 hours per week

The Documentation Specialist is responsible for creating, revising, and maintaining Standard Operating Procedures  (SOPs), Work Instructions (WIs), and related controlled documents that support Manufacturing activities. This role  ensures documentation complies with applicable regulations, internal quality systems, and site processes; drives  clarity and consistency in the related processes; and supports effective implementation through review, approval  routing, and training handoff. 

Primary objectives: 

• Produce accurate, auditable SOPs and WIs Manufacturing activities. 

• Maintain document control and change management best practices. 

• Collaborate with cross-functional teams to ensure documents reflect current processes and regulatory  expectations.

roles and responsibilities

• Develop, author, and revise SOPs, Work Instructions, forms, templates, and supporting documents related  to Manufacturing activities, including but not limited to manufacturing and packaging activities, labeling  formats, labeling reconciliation, labeling verification, and labeling equipment procedures. 

• Ensure documents meet quality and regulatory requirements (cGMPs, internal QMS procedures, and other  applicable standards). 

• Lead or participate in documentation change control activities: draft change requests, support impact  assessments, update documents, and coordinate approvals and training handoffs. 

• Work with subject matter experts (manufacturing, quality assurance, labeling development, regulatory  affairs, supply chain, engineering, etc.) to gather accurate technical content and validate procedural steps.

• Maintain controlled document master lists and ensure correct document lifecycle status in the Document  Management System (PLM/LMS/QMS). 

• Edit and format documents for clarity, consistency, grammar, and compliance with company templates and  style guides. 

• Support audits and inspections by providing documentation evidence and assisting in corrective/preventive  action documentation when related to Manufacturing documentation. 

• Provide training materials or coordinate with Training and/or the impacted functional areas to ensure  affected personnel are trained on new/revised SOPs and WIs. 

• Monitor and drive closure of documentation-related actions and support periodic document reviews / re approvals. 

• Perform other duties as assigned that support Manufacturing compliance and process improvement.

• Responsible for communicating business-related issues or opportunities to next management level.

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as  applicable.

how to succeed

Minimum education and experience: 

• Education: Bachelor’s degree in Life Sciences, Engineering, Technical Communication, Regulatory Affairs,  or related field preferred; equivalent combination of education and relevant experience considered.

• Experience: 3–5 years of related experience in technical writing or document control within the medical  device, pharmaceutical, or related regulated manufacturing environment. Experience specifically  supporting Manufacturing documentation preferred. 

• Experience of working in training departments/programs 

• Experience with document management systems (PLM, QMS, LMS or similar), controlled document  lifecycle, and change control. 

• Working knowledge of manufacturing processes, packaging operations, labeling systems, and equipment  is preferred. 

• Excellent technical writing and editing skills with strong attention to detail. 

• Ability to translate complex manufacturing/engineering processes into clear, concise, step-by-step  instructions. 

• Strong interpersonal and communication skills; able to work effectively with manufacturing operators,  engineers, quality, regulatory, and supply chain teams. 

• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and PDF toolsets (Adobe Acrobat). Familiarity  with structured authoring or template-based documentation preferred. 

• Experience with document control systems and electronic workflow routing. 

• Strong organizational and project management skills; ability to manage multiple documentation projects  and deadlines. 

• Familiarity with risk-based thinking and basic quality tools (e.g., CAPA, change control, root cause  analysis). 

• Ability to read and interpret technical drawings, specifications, and labeling artwork/formatting.

• Confidentiality and data integrity awareness.

Examples of desirable experience: 

• Experience in cGMP-regulated environments and familiarity with 21 CFR part 820, ISO 13485, or regional  equivalents. 

• Proven ability to author SOPs and WIs that are operationally clear and inspection ready.

• Experience coordinating cross-functional reviews and approval routing.

benefits

This role offers a very competitive hourly rate. This contract will run initially until the end of September 2026.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.