Hybrid Validation Engineer: GxP Systems & Equipment

Orion Pharma

Turku

Hybrid

EUR 55,000 - 76,000

Full time

4 days ago
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Job summary

Orion Pharma in Turku is seeking a dedicated validation expert responsible for qualifying equipment and computerised systems across our manufacturing operations. The role is permanent, full-time with hybrid working and some travel between sites.

You will define validation strategies, lead qualification activities, ensure compliance with GxP and internal procedures, and contribute to audits. You will collaborate with QA, Automation, Own Manufacturing, and external suppliers to deliver robust

Qualifications

  • Degree in engineering, technology, life sciences or related field with relevant work experience.
  • Strong understanding of GxP requirements.
  • Excellent documentation skills and attention to detail.
  • Strong problem-solving and communication abilities.

Responsibilities

  • Define validation and testing strategies for assigned projects.
  • Plan, perform, and lead qualification and validation activities for GxP-critical equipment and computerised systems.
  • Ensure validation documentation complies with regulatory requirements and internal procedures.
  • Maintain validated state through change control, periodic reviews and revalidation.
  • Provide qualification and validation expertise during audits and inspections.

Skills

GxP experience
Validation planning
Documentation
Audit readiness
Problem solving
Communication
Finnish language
English language

Education

Engineering degree

Tools

Qualification software
Risk assessment tools

Job description

Orion Pharma in Turku is seeking a dedicated validation expert responsible for qualifying equipment and computerised systems across our manufacturing operations. The role is permanent, full-time with hybrid working and some travel between sites.

You will define validation strategies, lead qualification activities, ensure compliance with GxP and internal procedures, and contribute to audits. You will collaborate with QA, Automation, Own Manufacturing, and external suppliers to deliver robust

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