Validation Engineer

In [xxxxx], 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 [xxxxx]. 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 [xxxxx] 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 [xxxxx] 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. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact For further information, please contact Automation Manager Liana Møsbæk at +[xxxxx]. Deadline 15 September 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.