Validation & GMP Specialist

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Hillerød

Are you an experienced Validation Specialist, Validation Engineer or Validation Lead ready to embark on your next opportunity? Are you eager to share your knowledge of manufacturing processes validation to support our production capacity expansion? Could your experience in defining validation strategies, within pharmaceutical industry, set the direction for validation, with a focus on robust processes and product quality? If these questions piqued your interest, then seize this unique opportunity today and apply for the Validation & GMP Specialist position in our Assembly team within Device Manufacturing Development (DMD) department. Come at join us at site Hillerød and join a truly international team ready to take on the journey in developing and rolling out the programme at our sites globally! The position The Validation & GMP Specialist opportunity has two pillars where you will be responsible for defining and executing device assembly validation and overseeing the workflow lifecycle through enhancing the delivery of manufacturing processes. This position is key in setting the direction for continuous improvement of science and risk-based validation, and standardising/ harmonising the validation strategy and activities across our sites globally through mentoring colleagues in validation! You will become a key member of the projects and will have involvement in:
  • Taking part in driving the standardisation and LEAN agendas within validation when implementing multiple lines at different sites to ensure that they conform with our corporate risk-based validation approach.
  • Managing and contributing to validation activities of the project, from basic design and establishing User Requirement Specification (URS) through to process risk assessment and validation (PV) of new production lines.
  • Set strategy of standardisation for running expansions programs and alignment between production sites where it is needed and necessary
  • Participating in audit and inspection activities.
  • Ensuring that newly developed production processes adhere to regulatory requirements.
  • Participate in all GMP activities connected to Regulatory aspects and changes.
    • In return, you can look forward to a rich professional experience with strong collaboration with multiple stakeholders from Corporate to local sites, R&D, Production, Suppliers, Quality Assurance (QA) and other specialists in multiple domains. You will have the opportunity to travel in this position where you can expect up to 30 days per year travelling to the Novo Nordisk sites and equipment vendors.

    Qualifications Your experiences include:
  • 8+ years of experience as Process or Validation Engineer within a regulated industry (pharmaceutical, medical devices, food…) and understanding of science and technical aspects of the manufacturing processes.
  • A degree in process engineering, pharmacy, or any other relevant field.
  • Have a strong quality mindset combined with experience within drug or device development.
  • Have expert knowledge and hands-on experience with quality risk management and validation within manufacturing or production. Experience in medical device manufacturing is highly advantageous.
  • Experienced with relevant software solutions e.g. MS Office 365, Teams, e-TIMS etc.
  • Fluent in English (both written and spoken).
    • Whilst we avoid placing people in boxes, there are certain traits that we believe will help you thrive in this role… you are well organised, have a focus on quality and see yourself as innovative thinker to act as lead in our LEAN activities and to challenge the status quo! Being open minded, ability to adapt to new situations, having strong communication and stellar stakeholder management skills, are skills which you see as being your strengths with the ability to use these to navigate local sites and their practices. You are a true team-player at heart: you like to collaborate with colleagues and stakeholders to achieve common goals. As a specialist, we would like you to offer your expertise to act as a role model for your highly skilled colleagues and that you are ready to support the people around you. About the department You will join Device Manufacturing Development (DMD) and the Assembly department. We are a key function, bridging Device R&D to production. We are involved in the development of new devices, and responsible of the development and implementation of manufacturing capacity worldwide for new and marketed products. Our belief is that a diverse workforce directly supports our goal to provide the highest-quality work: we are almost 40 different nationalities in DMD right now, coming from different levels of experience and educational backgrounds. The Assembly department, located in Hillerød, includes 80+ highly engaged skilled professionals from project managers, specialists, validation, process, and science experts. We are collaborating with multiple stakeholders and striving for excellence in project execution, science engineering, innovation, and technology. Working at Novo Nordisk At Novo Nordisk, 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, contact Ariane Giguere-Robert (Manager, Assembly Single Dose Devices) at: [email protected] Deadline 4 August 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 Novo Nordisk 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 18.7.2024, men kan have været deaktiveret og genaktiveret igen.

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