Job Description Summary

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

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Additional Information