IT Validation Manager
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Måløv
On the edge of the future
Come and join a team who are frontrunners in Novo Nordisk in relation to digitalisation, future manufacturing processes and risk-based decision making. As a team member you enjoy working in an open, dynamic, and social atmosphere with a strong focus on technical and scientific skills. Your new team consists of 13 dedicated colleagues maintaining the overall IT infrastructure and compliance of various systems within production and production development. About the department
Emerging Technology (ET) Oral Products Development (OPDev) is an area within Product Supply Quality & IT, organised in eight departments and based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms. ET OPDev Technical Support department consists of three teams. The position
You will join the department - OPDev Technical support – which consists of three teams, contributing with a broad range of skills, such as facilities management, Project management, maintenance, calibration, qualification, IT, and broad support to ensure daily operations of GsP (Good Supply Practice) and GMP (Good Manufacturing Practice) IT systems. You will be a part of our IT & Quality team. As IT Validation Manager your main tasks will be focused on implementing and validating process equipment, including tasks like:
• Participate in and drive validation planning
• Define IT requirement specifications for new systems
• Cooperate with System Managers and equipment suppliers about system design
• Drive IT risk assessments
• Drive and supervise test and verifications
• Ensure compliance with internal IT procedures
• Provide general IT Compliance consulting to stakeholders and IT colleagues
• Represent the department during internal and external audits Every day you will work in an ever-changing, project-driven environment, alongside with some of the most skilled and passionate experts in the world… your colleagues. You will become a part of a cooperative and demanding environment in OPDev Technical Support with more than 35 dedicated and experienced employees. Qualifications
You preferably have a master's or bachelor's degree but most importantly have minimum 5 years of qualification or validation experience (from the pharmaceutical industry or a consultancy company). You have worked on GMP compliant, manufacturing equipment implementation projects and you are familiar with the US and European GMP rules.
Expertise within Automation & IT technologies like PCS (SCADA), IT infrastructure, software development or MES systems will be considered as an advantage. On a personal level you:
Are passionate about working in the quality management area of computerized systems in a pharmaceutical or biotech environment.
Have a personal drive and are comfortable with customer relations and your colleagues describe you as proactive and cooperative.
Are proficient in spoken and written Danish and English, required for this position.
We look forward to welcoming you, in our team! 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, please contact Senior IT Validation Manager, Bent Kattrup at +45 3077 7680 or Associate Manager, Nicolai Kristensen at +45 3075 3501.
Deadline 30th of July 2023. 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. Please also attach your diploma. 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.
Come and join a team who are frontrunners in Novo Nordisk in relation to digitalisation, future manufacturing processes and risk-based decision making. As a team member you enjoy working in an open, dynamic, and social atmosphere with a strong focus on technical and scientific skills. Your new team consists of 13 dedicated colleagues maintaining the overall IT infrastructure and compliance of various systems within production and production development. About the department
Emerging Technology (ET) Oral Products Development (OPDev) is an area within Product Supply Quality & IT, organised in eight departments and based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms. ET OPDev Technical Support department consists of three teams. The position
You will join the department - OPDev Technical support – which consists of three teams, contributing with a broad range of skills, such as facilities management, Project management, maintenance, calibration, qualification, IT, and broad support to ensure daily operations of GsP (Good Supply Practice) and GMP (Good Manufacturing Practice) IT systems. You will be a part of our IT & Quality team. As IT Validation Manager your main tasks will be focused on implementing and validating process equipment, including tasks like:
• Participate in and drive validation planning
• Define IT requirement specifications for new systems
• Cooperate with System Managers and equipment suppliers about system design
• Drive IT risk assessments
• Drive and supervise test and verifications
• Ensure compliance with internal IT procedures
• Provide general IT Compliance consulting to stakeholders and IT colleagues
• Represent the department during internal and external audits Every day you will work in an ever-changing, project-driven environment, alongside with some of the most skilled and passionate experts in the world… your colleagues. You will become a part of a cooperative and demanding environment in OPDev Technical Support with more than 35 dedicated and experienced employees. Qualifications
You preferably have a master's or bachelor's degree but most importantly have minimum 5 years of qualification or validation experience (from the pharmaceutical industry or a consultancy company). You have worked on GMP compliant, manufacturing equipment implementation projects and you are familiar with the US and European GMP rules.
Expertise within Automation & IT technologies like PCS (SCADA), IT infrastructure, software development or MES systems will be considered as an advantage. On a personal level you:
Are passionate about working in the quality management area of computerized systems in a pharmaceutical or biotech environment.
Have a personal drive and are comfortable with customer relations and your colleagues describe you as proactive and cooperative.
Are proficient in spoken and written Danish and English, required for this position.
We look forward to welcoming you, in our team! 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, please contact Senior IT Validation Manager, Bent Kattrup at +45 3077 7680 or Associate Manager, Nicolai Kristensen at +45 3075 3501.
Deadline 30th of July 2023. 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. Please also attach your diploma. 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 11.7.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Måløv
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