Technical Documentation Specialist

GE HealthCare; Helsinki; On-site; EUR 52,000 - 68,000; Full time

Job summary

GE HealthCare is seeking a Technical Documentation Specialist to create and maintain documentation for machine qualification activities, ensuring IQ/OQ/PQ protocols meet functional and safety requirements.

You will collaborate with Engineering, Quality Assurance, and Production to translate complex technical information into clear, audit-ready documentation and manage version control in the document management system.

Qualifications

• Bachelor’s degree or equivalent in a relevant field, preferably Engineering.
• Proven experience in technical writing in manufacturing or regulated environments.
• Familiarity with IQ/OQ/PQ and qualification processes.
• Ability to interpret and structure technical information clearly.

Responsibilities

• Create and maintain machine qualification documentation (IQ/OQ/PQ) with reports.
• Collaborate with Engineering, QA, and Production to gather information and ensure accuracy.
• Translate complex technical data into clear, audit-ready documentation.
• Ensure compliance with industry standards and internal procedures.
• Manage version control and traceability in the document management system.
• Support continuous improvement by updating docs after equipment upgrades or audits.
• Assist in developing SOPs and work instructions for machine operation and qualification.

Skills

Technical writing

Regulatory understanding

Independent worker

Communication skills

Engineering background

Education

Bachelor’s degree in Engineering

Tools

Microsoft Word

Excel

Adobe Acrobat

Document management systems

Job description

We are seeking a technically skilled Technical Documentation Specialist to support our production lines by creating and maintaining documentation for machine qualification activities. This role is critical to ensuring that production equipment meets functional and safety requirements through clear, accurate, and compliant documentation

We are seeking a technically skilled Technical Documentation Specialist to support our production lines by creating and maintaining documentation for machine qualification activities. This role is critical to ensuring that production equipment meets functional and safety requirements through clear, accurate, and compliant documentation

Job Description

Roles and Responsibilities

• Create and maintain machine qualification documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Collaborate closely with Engineering, Quality Assurance, and Production teams to gather technical information and ensure documentation accuracy and completeness.
• Translate complex technical information into clear, structured, and easy-to-understand documentation for internal and external audits.
• Ensure that all documentation complies with industry standards, internal procedures, and regulatory requirements.
• Manage document version control and traceability within document management systems.
• Support continuous improvement initiatives by updating documentation based on equipment upgrades, process changes, or audit findings.
• Assist in the development of Standard Operating Procedures (SOPs) and work instructions related to machine operation and qualification.

Required Qualifications

• Bachelor’s degree or equivalent qualification in a relevant field, preferably Engineering or a related technical discipline.
• Proven experience in technical writing, preferably within a manufacturing, industrial, or regulated environment.
• Familiarity with equipment qualification processes and documentation standards, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Solid understanding of manufacturing equipment, automation systems, and validation principles.
• Excellent written and verbal communication skills in Finnish.
• Written and verbal communication skills in English
• Proficiency in using documentation tools such as Microsoft Word, Excel, Adobe Acrobat, and document management systems.
• Ability to work independently and manage multiple documentation projects simultaneously

Desired Characteristics

• Experience working in regulated environments, such as the medical device, pharmaceutical, or food manufacturing industries.
• Ability to interpret CAD drawings, technical schematics, and equipment manuals.

What We Offer

• The opportunity to work in a dynamic and innovative manufacturing environment.
• Competitive compensation and benefits.
• Opportunities for professional development and training.
• A collaborative team culture focused on quality and continuous improvement.
• The chance to participate in exciting projects as part of a team responsible for ramping up production lines and ensuring that manufacturing equipment meets all defined functional and safety requirements

Additional Information

Relocation Assistance Provided: No