Contura International A/S, is looking for a competent Process Engineer. Contura International – is a Copenhagen based medical technology company that develops, manufactures and commercializes soft tissue fillers based on proprietary hydrogel technology. The facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products. Contura has recently obtained FDA approval for its product for treating stress urinary incontinence in women, Bulkamid, and a manufacturing license (§39) for production of its hydrogel technology as a medicinal product.
The company’s development, manufacturing and testing processes comply with the European Medical Devices directive 93/42/EEC and the quality system meets the standards required to obtain ISO 13485:2016.
The company offers:
A challenging position in a company with dedicated people and a strong pioneer spirit.
They reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.
There is a natural focus on the ongoing development of your professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.
As an engineer for production, you will be part of the production team where you will contribute to maintenance and update of the product and process documentation, e.g. process validations, product stability testing reports, risk analysis evaluations, design changes, continuous improvements and process and product development etc.
You will be a driver in addressing non-conformities, corrective and preventive actions as well as change requests.
You will assist regulatory affairs as a subject matter expert in preparing change notifications and supplements to regulatory agencies globally, including US FDA.
The ideal candidate would have some years’ experience within production of medical devices and product development as per ISO 13485 and 21 CFR part 820. Also, experience within EU GMP as per Eudralex – Volume 4 would be an advantage. Knowledge of design control would be an advantage but not a requirement. If you are familiar with statistical techniques for process controls and monitoring using SAS JMP it is an advantage.
A part of the work is hands on, e.g. to operate certain process equipment during production.
- You have a master’s degree as: Engineer, chemist, pharmacist, microbiologist or other relevant natural science
- You have experience from either medical device (preferred) or pharmaceutical industry
- Knowledge of statistical techniques preferred
- Knowledge of design control is an advantage
- Fluent in Danish and English required (oral and writing)
- Strong team player
- Enjoy problem solving and thinking beyond the envelope
- As a small and tightly knit team with a bit of a family atmosphere, we would like you to be an honest, supportive and loyal member
- You are well structured and meet deadlines
- A sense of humor will go a long way
Application and further information:
If you would like additional information about this position before you apply using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: email@example.com