Validation Engineer

Orion Corporation; Turku; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Orion Pharma is seeking a validation expert to lead qualification activities for GxP-critical equipment and computerised systems at our Turku site. The role involves defining strategies, ensuring regulatory compliance, and maintaining validated states across projects.

You will travel between sites as required and collaborate with QA, Automation, Own Manufacturing, and external suppliers to drive quality and compliance in a fast-paced manufacturing environment.

Qualifications

• Good understanding of GxP requirements.
• Strong documentation skills and attention to detail.
• Good problem-solving and communication skills.
• Fluency in both Finnish and English.

Responsibilities

• Defining validation and testing strategies for assigned projects.
• Planning, performing, and leading qualification and validation activities for GxP-critical equipment and computerised systems.
• Ensuring validation documentation complies with applicable regulatory requirements and internal procedures.
• Maintaining the validated state of GxP-critical equipment and computerised systems through change control, periodic reviews, and revalidation.
• Providing qualification and validation expertise during audits and inspections.

Skills

GxP understanding

Documentation

Problem-solving

Communication skills

Finnish fluency

English fluency

Education

Relevant degree in engineering/technology/life sciences or related field

Job description

In this role, you will be responsible for the validation of equipment and computerised systems across our manufacturing operations.

You will also contribute to technical projects as a validation expert, working closely with project teams and other stakeholders.

This is a permanent, full-time position based primarily in Turku, with the possibility for hybrid working. The role involves some travel, mainly between our manufacturing sites. Travel frequency and the duration of business trips will vary depending on the project and its phase.

Responsibilities

Your key responsibilities include:

• Defining validation and testing strategies for assigned projects
• Planning, performing, and leading qualification and validation activities for GxP-critical equipment and computerised systems
• Ensuring validation documentation complies with applicable regulatory requirements and internal procedures
• Maintaining the validated state of GxP-critical equipment and computerised systems through change control, periodic reviews, and revalidation
• Providing qualification and validation expertise during audits and inspections

What you can expect from us

We offer a versatile and challenging role with excellent opportunities for professional development. As part of the Validation and Calibration group, you will work in a collaborative and supportive team with strong professional expertise.

In this role, you will collaborate closely with a wide range of stakeholders, including QA, Automation, Own Manufacturing, and external suppliers.

At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

• A relevant degree in engineering, technology, life sciences or a related field, along with relevant work experience
• Good understanding of GxP requirements
• Strong documentation skills and attention to detail
• Good problem-solving and communication skills
• Fluency in both Finnish and English

Previous experience in qualification and validation, as well as with computerised systems in a regulated environment, is considered an advantage.

You are solution-oriented and work in a systematic and conscientious manner. You are comfortable taking responsibility, working independently, and managing multiple tasks and projects. At the same time, you enjoy collaborating with different stakeholders and are motivated to continuously develop your expertise in qualification and validation.

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.

Your new team

Orion's Global Operations covers the entire pharmaceutical manufacturing process, from sourcing of raw materials to the manufacture of products, packaging and delivery to customers. We are also responsible for the industrialisation of new products and product lifecycle management.

In Global Operations we have approximately 1,600 professionals working in Production, our external supplier network (Externally Sourced Operations) and Fermion Oy (API manufacturing and marketing). In addition, the organisation includes Supply Chain & Procurement, Technical Operations, Facility Management, EHS (Environment, Health and Safety), CPD&LCM (Commercial Product Development & Product lifecycle management) and Operations Development.

The Technical Operations unit is responsible for Orion's supply chain production technology and its maintenance. The main task of the unit is to ensure that the production equipment, facilities and systems meet the quality, safety and capacity requirements set for them. In the Validation and Calibration department, our team of around 25 experts is responsible for the validation and calibration of systems, equipment and facilities.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.