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Validation Engineer with automation skills for the Digital Innovation team

Descripción del puesto:

Are you ready for a unique opportunity to shape the future of building future automated laboratories in Novo Nordisk? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as a Validation Engineer in Oral Protein Formulation (OPF).

About the department

OPF is part of Novo Nordisk's Research & Development (R&D) family and acts as a link from research to the future of our production systems. Our ambition is to improve patients lives by developing the world's finest tableted biologicals.

The position is anchored in 'Future Manufacturing and Digital Innovation' in Måløv, and you will be joining a team of 15 highly skilled innovators, interns & students with different scientific backgrounds, ranging from data scientists to process and to automation engineers. The team is responsible for building laboratory automation to enhance capacity; allowing us to meet a growing target for the development of oral pipeline of products and preparing us for the future of manufacturing.

The position and responsibilities

As Validation Engineer, you will be working in a cross-disciplinary team, consisting of automation engineers, data engineers and modelling scientists, where you will be helping bring laboratory automation to a GSP/GMP level of readiness. You will take a lead in validating and qualifying new robotic solutions/ automation projects and custom software in laboratory setting.

Qualifications and skills

Preferably, you have an educational background as an industrial, IT or mechanical engineering or technician, etc. You have sufficient insight in automation to lead the qualification tasks and can facilitate verification and validation activities including test execution, documentation review and approval. Ideally, you have been responsible for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications, Validation Plan/Report (VPL/VR), Installation/Operational/Performance Qualification Protocol/Report (xQP/R), Operation and Maintenance SOPs.

In addition, you have the following qualifications:

* Experience with qualification of GAMP level 5 software GxP and FDA 21CFR part 11

* Solid project management skills

* Detail oriented mindset and quickly acquire new knowledge

* Strong skills with validation and qualification of software and automation/robots' projects in regulated industries

* Experience with life cycle documentation (URS, FDS, TDS)

We are looking for a team-player who is dedicated and enjoy work independently and in a team. On a personal level, you are structured and skilled at knowledge sharing and you are not afraid to reach out to others for help or knowledge when relevant. You have a sincere interest in exploring new technologies and you enjoy being part of a team where it is important to have fun and where we work in a collaborative and trusting atmosphere.

Contact

For further information, please contact Hanne Winning at + 4x xxxxxxx4.

Deadline

15th of May 2022.

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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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Validation Engineer with automation skills for the Digital Innovation team

Descripción del puesto:

Are you ready for a unique opportunity to shape the future of building future automated laboratories in Novo Nordisk? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as a Validation Engineer in Oral Protein Formulation (OPF).

About the department

OPF is part of Novo Nordisk's Research & Development (R&D) family and acts as a link from research to the future of our production systems. Our ambition is to improve patients lives by developing the world's finest tableted biologicals.

The position is anchored in 'Future Manufacturing and Digital Innovation' in Måløv, and you will be joining a team of 15 highly skilled innovators, interns & students with different scientific backgrounds, ranging from data scientists to process and to automation engineers. The team is responsible for building laboratory automation to enhance capacity; allowing us to meet a growing target for the development of oral pipeline of products and preparing us for the future of manufacturing.

The position and responsibilities

As Validation Engineer, you will be working in a cross-disciplinary team, consisting of automation engineers, data engineers and modelling scientists, where you will be helping bring laboratory automation to a GSP/GMP level of readiness. You will take a lead in validating and qualifying new robotic solutions/ automation projects and custom software in laboratory setting.

Qualifications and skills

Preferably, you have an educational background as an industrial, IT or mechanical engineering or technician, etc. You have sufficient insight in automation to lead the qualification tasks and can facilitate verification and validation activities including test execution, documentation review and approval. Ideally, you have been responsible for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications, Validation Plan/Report (VPL/VR), Installation/Operational/Performance Qualification Protocol/Report (xQP/R), Operation and Maintenance SOPs.

In addition, you have the following qualifications:

* Experience with qualification of GAMP level 5 software GxP and FDA 21CFR part 11

* Solid project management skills

* Detail oriented mindset and quickly acquire new knowledge

* Strong skills with validation and qualification of software and automation/robots' projects in regulated industries

* Experience with life cycle documentation (URS, FDS, TDS)

We are looking for a team-player who is dedicated and enjoy work independently and in a team. On a personal level, you are structured and skilled at knowledge sharing and you are not afraid to reach out to others for help or knowledge when relevant. You have a sincere interest in exploring new technologies and you enjoy being part of a team where it is important to have fun and where we work in a collaborative and trusting atmosphere.

Contact

For further information, please contact Hanne Winning at + 4x xxxxxxx4.

Deadline

15th of May 2022.

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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Modtag jobannoncer der minder om dette job i din indbakke.




Når du tilmelder dig accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.

Andre job der minder om dette

Scientist for Mammalian Upstream Manufacturing

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Are you our new Graduate Engineer in Virum?

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