Equipment Qualification Responsible
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Måløv
Are you passionate about compliance and qualification of production equipment? Are you eager to be part of Novo Nordisk’s major quest within tablets? Do you want to influence a department working with processes on the edge of the future? If yes, you are the Qualification ´Responsible that we are looking for in Emerging Technologies (ET) Oral Product Development (OPDev) Technical Support. About the Department ET OPDev is an area within Product Supply Quality & IT, organised in six departments and is 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 five teams, we are currently expanding our Engineering support & projects team, consisting of 14 dedicated colleagues all contributing to implementation of new equipment, support to clinical production and project management.
Responsibilities like qualification of equipment and maintaining validated state are an absolute essential part of our ability to produce in compliance with GMP standards. The position
This is a key role in our business-critical efforts to ensure and maintain the facility’s license to operate.
Your primary focus will be challenges related to implementation and verification of new equipment as well as general support for the already installed GMP equipment in the Oral Pilot Plant (OPP) facility.
Main responsibilities will be to handle: • Qualification of new equipment, re-qualification and evaluation on existing
equipment • Technical support for the on-going GMP production in OPP • Cooperation with QA, Development, Production, External stakeholders, Vendors • Equipment related Change Requests and Deviations • Project validation responsible on minor equipment implementations Other areas of responsibilities will be support to existing or new equipment in our non-GMP Facility and laboratories. Qualifications In order to succeed in this role, we believe that your profile should be aligned with the bullets listed below. However, we acknowledge that success can take many forms, so please do apply even if you do not tick all the boxes. • Have a bachelor’s or master’s degree within engineering or similar technical field
• Have a minimum 1 year of experience as equipment/qualification responsible, preferably in a pharmaceutical company
• Have a solid LEAN mindset and a structured way of working
• Have excellent communication skills
• Are fluent in Danish and English both written and spoken
On a personal level, you have a positive can-do attitude and thrive in an everchanging environment. You connect easily with all organisational levels due to your excellent communication and people skills. You can quickly create an overview over possible solutions, consequences and needed compromises and you have a passion for setting structure and standards.
We look forward to welcome 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 Associate Manager Søren Friis +45-30753105 Deadline 1 April 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.
Responsibilities like qualification of equipment and maintaining validated state are an absolute essential part of our ability to produce in compliance with GMP standards. The position
This is a key role in our business-critical efforts to ensure and maintain the facility’s license to operate.
Your primary focus will be challenges related to implementation and verification of new equipment as well as general support for the already installed GMP equipment in the Oral Pilot Plant (OPP) facility.
Main responsibilities will be to handle: • Qualification of new equipment, re-qualification and evaluation on existing
equipment • Technical support for the on-going GMP production in OPP • Cooperation with QA, Development, Production, External stakeholders, Vendors • Equipment related Change Requests and Deviations • Project validation responsible on minor equipment implementations Other areas of responsibilities will be support to existing or new equipment in our non-GMP Facility and laboratories. Qualifications In order to succeed in this role, we believe that your profile should be aligned with the bullets listed below. However, we acknowledge that success can take many forms, so please do apply even if you do not tick all the boxes. • Have a bachelor’s or master’s degree within engineering or similar technical field
• Have a minimum 1 year of experience as equipment/qualification responsible, preferably in a pharmaceutical company
• Have a solid LEAN mindset and a structured way of working
• Have excellent communication skills
• Are fluent in Danish and English both written and spoken
On a personal level, you have a positive can-do attitude and thrive in an everchanging environment. You connect easily with all organisational levels due to your excellent communication and people skills. You can quickly create an overview over possible solutions, consequences and needed compromises and you have a passion for setting structure and standards.
We look forward to welcome 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 Associate Manager Søren Friis +45-30753105 Deadline 1 April 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.
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 18.3.2024, 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.
- Øvrige
- Måløv
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