Validation Engineer

3 weeks ago

Kalundborg, Denmark Novo Nordisk AS - Nn1 Full time

In Novo Nordisk, we have a passion for improving patients’ lives all over the world, and we are therefore expanding our API Manufacturing capacity in Kalundborg. 

Will you help us bringing that passion to life, by taking part of this large and complex project? Would you like to further develop your expertise within validation and quality control? Do you feel ready to start working in a dynamic team consisting of IT/Automation experts, project manager and validation experts? 

If so, you might be our new Validation Engineer, who will help drive the compliance and validation activities in Novo Nordisk. Read on and apply today
 

The Position

As a Validation Engineer, your responsibilities will include defining the validation strategy, planning, and reporting for a specific implementation of an IT system or computerized equipment that has an impact on GxP (healthcare).

You will be joining the M3 IT/Automation department team, where we work closely with the Line of Business (LoB) and other stakeholders to understand the validation scope. Additionally, you will serve as a liaison between the IT & automation team, process areas, Quality Assurance (QA), and the project validation department.

Your tasks will also involve working as a validation sparring partner for our IT/Automation & process experts to ensure the appropriate level of quality throughout the project.

Your main focus will be on:
• Participating in large scale expansion projects as the IT/automation validation expert thus responsible for execution of validation and quality control activities.
• Taking responsibility for validation activities for the project(s) e.g., planning, documentation, coordination, and reporting and ensuring that these are executed effectively.
• Providing help in developing and optimizing our approach to validation and quality control work, ensuring we verify and validate the right things at the right level, supporting a risk-based approach to verification.
• Performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.
• Ensuring the validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.

Qualifications

To be considered for this position you should have:
• A min. bachelor’s degree in Automation, IT, biotechnology, production engineering, or similar field.
• Experience within validation from pharma industry or other regulated industries, with GxP compliance experience, preferably also in working with Good Automated Manufacturing Practice (GAMP).
• Experience in working with validation of process, computerized equipment or IT systems, while experience within IT/OT is considered an advantage.
• Fluency in verbal and written English.

On a personal level, you are proactive and thrive in a challenging, dynamic, and ever-changing environment. To succeed in this position, it is crucial to possess the skills of multitasking and maintaining a continuous focus on achieving results. Essential skills for this role include being open-minded, positive, and confident in collaborating with external parties such as customers, vendors, and consultants.

In this role, having a quality mindset and the ability to complete tasks within deadlines is essential. We are looking for a colleague who possesses excellent stakeholder management, facilitation, and communication skills, along with a strong work ethic, an unwavering sense of responsibility, and a drive for success.

About the department

Today, 3,200 employees of Novo Nordisk Kalundborg produce half of the world’s insulin and a number of biopharmaceutical products. With more than 50 years of expertise in large-scale biotech manufacturing, we are the world’s largest insulin-producing facility. By joining Novo Nordisk Manufacturing in Kalundborg, we promise you a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. 

Together, we make a difference every day for more than 30 million people living with diabetes and other chronic diseases. This is your opportunity to be part of our exciting journey.

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