Validation Engineer

Do you want to join the creation and development of the new manufacturing for our Continence Care segment within Coloplast?

Be a service partner for/and support the production process, from a quality function, to produce the products our users’ needs in the quality needed?

Then look at this position: Validation Engineer

Here you will play a key role in the quality of the products produced as a partner in process validation. You will play a pivotal role in ensuring the success of our roll-out plan as the process validation is a key compliance component and the gate keeper for starting production at our new site. Furthermore, the validation of our processes is the foundation for the quality of our products and therefore for our users.

An unexhausted list of what You will do:

• Support and promote the quality culture for the whole site
• Lead, execute and document software and process validations at site
• Be the approver of software and process validation documentation
• Train, instruct and guide the organization on site within validation
• Support production – Partner towards production for validation and revalidation
• Create and facilitate process risk assessments including driving mitigation discussions for process risks
• Participate in projects in relation to validation activities, and potential problem solving of technical process problems
• Be the receiving end for Test Methods transfers
• Coordination of validation activities across the site and close cooperation with our other sites and headquarter on validation requirements

Your Qualifications:

• Academic background: A relevant academic background (B.Sc. or higher).
• Experience: 
  • Minimum 2 years as a Validation Engineer / Test Engineer or similar within a production environment
  • Solid understanding within the field of Validation and Quality i.e. GDP and GMP etc. (Quality Assurance experience is a plus)
  • Knowledge of software and process validation and process risk assessment
  • Project knowledge and experience
  • Production knowledge – Value chain understanding
• Business understanding: Holistic understanding of End-To-End production
• Language Proficiency: Fluent in spoken and written English (other languages are a plus).

Timing:

• Expected start is February, 2025.
• Workplace will be Felgueiras in Portugal
  • During the first year the workplace will be between a rented office in Felgueiras, Portugal; and a long training period at one of our Hungarian sites for approximately 4 months and visits of various lengths (1-2 weeks stints) for training and introductions at our other sites in Hungary and Denmark.
  • The travel program will be defined together with the manager.

Please note that all applications must be submitted in English.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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