IT Validation Manager
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Måløv
IT Validation Manager On the edge of the future
Come and join a department 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 team consists of 15 dedicated colleagues maintaining the overall IT infrastructure and compliance of various systems within production and production development within the Product Supply family in Novo Nordisk. About the department
As part of OP Development, you make a real difference for patients with chronic diseases across the world. We develop and formulate all new processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. The Oral Product Development (OPDev) is an area within Emerging Technologies. OPDev employs approximately 700 highly skilled people organised in seven departments and is based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I, II and III covering a broad and exciting range of process technologies for solid dosage forms. The position You will join the department - OPDev Technical support – which consists of five teams, contributing with a broad range of skills, such as maintenance, calibration, qualification, automation, digitalization, IT, and universal support to ensure daily operations of GsP (Good Scientific Practice) and GmP (Good Manufacturing Practices) IT systems. You will be a part of our IT-team.
As an IT Validation Manager your main tasks will be focused on implementing and validating process equipment, including tasks like: Participate in and drive quality planning Give input to requirement specifications Cooperate with equipment suppliers about system design Drive IT risk assessments Drive and supervise test and verifications Conduct IT compliance assessments Provide general IT Compliance consulting to stakeholders
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 OPF (Oral Protein Formulation) 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.
Contact
For further information regarding IT tasks please contact IT Solution Lead, Bent Kattrup at +45 3077 7680, or Manager Nicolai Kristensen on +45 3079 2697 for general Novo Nordisk questions. Deadline 29 February 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 and please attach your diploma. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 department 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 team consists of 15 dedicated colleagues maintaining the overall IT infrastructure and compliance of various systems within production and production development within the Product Supply family in Novo Nordisk. About the department
As part of OP Development, you make a real difference for patients with chronic diseases across the world. We develop and formulate all new processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. The Oral Product Development (OPDev) is an area within Emerging Technologies. OPDev employs approximately 700 highly skilled people organised in seven departments and is based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I, II and III covering a broad and exciting range of process technologies for solid dosage forms. The position You will join the department - OPDev Technical support – which consists of five teams, contributing with a broad range of skills, such as maintenance, calibration, qualification, automation, digitalization, IT, and universal support to ensure daily operations of GsP (Good Scientific Practice) and GmP (Good Manufacturing Practices) IT systems. You will be a part of our IT-team.
As an IT Validation Manager your main tasks will be focused on implementing and validating process equipment, including tasks like:
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 OPF (Oral Protein Formulation) 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.
Contact
For further information regarding IT tasks please contact IT Solution Lead, Bent Kattrup at +45 3077 7680, or Manager Nicolai Kristensen on +45 3079 2697 for general Novo Nordisk questions. Deadline 29 February 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 and please attach your diploma. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 14.2.2024, 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.
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