Validation Process Engineer
- Production
- Denmark - Hillerød
Device manufacturing & Sourcing (DMS) seeks a talented engineer to assist us with validation and qualification activities for injection moulding tools .If you have a great quality mindset and always strive for improvements and possess in-depth knowledge within validation and qualification then go for this job.
About the department
DMS is focused on introduction of moulded components for medical devices, maturation of the production setup to excellence and sourcing the components to sister sites abroad. The area is at a high development pace and we need a validation responsible in Mould Pipeline & Validation (MPV), which is a team responsible for ordering and approval of injection moulds for plastic parts for prefilled devices produced internally in Hillerød DK and on various production sites worldwide.
The Job
You will be responsible for various validation activities such as execution, writing and reviewing validation plans, protocols, and reports associated with Installation Qualification, (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to ensure quality and compliance. You will also be responsible for continually improving the validation documentation and related standard operating procedures as well as you will be involved in problem solving when specifications or requirements are not met.
You will have a very high degree of influence and planning of your own job and daily tasks within the validation activities as well as working with the highest quality and complex equipment within injection moulding and tooling. We can offer you a workplace with an international atmosphere, surrounded by talented and dedicated colleagues with whom you can exchange experiences.
Qualifications
You have a background as mechanical, biomedical or validation engineer or similar experience. Preferably you have some experience with validation and/or qualification of production tools within the pharmaceutical industry or other regulated industry. Furthermore, you have a good understanding of GxP and a high quality mind-set. You possess good interpersonal skills, are process oriented and have the ability to communicate simple and uncomplicated. It is also important you support the rest of us in creating a positive spirit and a good department. Communication in English and Danish in speech and writing is a necessity. The position also includes travel.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to do the same in a global business environment.
You are welcome to send your application in Danish or in English, whichever you prefer.
Contact
For further information, please contact Laura Sørensen at +45 3075 0463.
Deadline
20 january 2014.
- Production
- Denmark - Hillerød
Device manufacturing & Sourcing (DMS) seeks a talented engineer to assist us with validation and qualification activities for injection moulding tools .If you have a great quality mindset and always strive for improvements and possess in-depth knowledge within validation and qualification then go for this job.
About the department
DMS is focused on introduction of moulded components for medical devices, maturation of the production setup to excellence and sourcing the components to sister sites abroad. The area is at a high development pace and we need a validation responsible in Mould Pipeline & Validation (MPV), which is a team responsible for ordering and approval of injection moulds for plastic parts for prefilled devices produced internally in Hillerød DK and on various production sites worldwide.
The Job
You will be responsible for various validation activities such as execution, writing and reviewing validation plans, protocols, and reports associated with Installation Qualification, (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to ensure quality and compliance. You will also be responsible for continually improving the validation documentation and related standard operating procedures as well as you will be involved in problem solving when specifications or requirements are not met.
You will have a very high degree of influence and planning of your own job and daily tasks within the validation activities as well as working with the highest quality and complex equipment within injection moulding and tooling. We can offer you a workplace with an international atmosphere, surrounded by talented and dedicated colleagues with whom you can exchange experiences.
Qualifications
You have a background as mechanical, biomedical or validation engineer or similar experience. Preferably you have some experience with validation and/or qualification of production tools within the pharmaceutical industry or other regulated industry. Furthermore, you have a good understanding of GxP and a high quality mind-set. You possess good interpersonal skills, are process oriented and have the ability to communicate simple and uncomplicated. It is also important you support the rest of us in creating a positive spirit and a good department. Communication in English and Danish in speech and writing is a necessity. The position also includes travel.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to do the same in a global business environment.
You are welcome to send your application in Danish or in English, whichever you prefer.
Contact
For further information, please contact Laura Sørensen at +45 3075 0463.
Deadline
20 january 2014.