Process Engineer for Manufacturing Development
Contura International A/S, is looking for a new Process Engineer to join our Manufacturing Development department.
The company offers
A challenging position in a growing company with dedicated people and a strong pioneer spirit. We 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 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.
The position
As an engineer for the Manufacturing Development department, you will be part of a small team where you will contribute to the continued development of our facility, production, products and processes. This includes tasks within process validation, stability testing, risk management and design.
You will be involved in projects and change requests as well as relevant non-conformities or corrective and preventive actions.
Part of the position responsibilities include assisting cross-functional departments (e.g., regulatory affairs, Quality Assurance and Clinical Affairs) with tasks and subject matter expertise where required.
The ideal candidate would have experience in process validations, medical device production and product development. Also, experience within ISO 13485, 21 CFR part 820 or EU GMP as per Eudralex - Volume 4 would be an advantage. Knowledge of risk management and design control would be an advantage but not a requirement.
Professional profile/qualifications
- You have a master’s degree as: Engineer, chemist, pharmacist, microbiologist or other relevant natural science. Knowledge of validations preferred
- Experience from either medical device (preferred) or pharmaceutical industry is an advantage
- Knowledge of design control is an advantage
- Fluent in Danish and English required (oral and writing)
Personal Profile
- Strong team player and
- Enjoy problem solving and capable of thinking out-of-the-box
- 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
Send your application and your CV via the apply button no later than 13-06-2025.
For further information contact Rico Røder Riis (head of R&D) at Rico.riis@Contura.com.
Job interviews may be conducted prior to the application deadline.
For more information about the company, please visit www.contura.com, www.bulkamid.com and www.arthrosamid.com.
Company description
Contura International A/S (Contura) is a Copenhagen based medical technology company that develops and manufactures innovative medical products in the fields of orthopaedics, soft tissue augmentation and animal health using its unique, patented hydrogel technology.
The manufacturing 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 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. Production is performed in ISO class 8/GMP C cleanroom.
Contura is currently 120+ employees but is growing by the month.
Apply with QuickApply on Jobindex.
