Are you ready to work in a rapidly growing Biotech start-up? Helping out with your initiative and your problem-solving attitude? We are looking for you to join our great team!

About us

BluSense Diagnostics is an award-winning, innovative start-up in the med-tech business, working hard to become the global leader within infectious point-of-care diagnostics. We combine complex scientific areas such as nanotechnology, molecular biology, biochemistry, optics, hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases such as dengue fever which affects over 390 million human beings each year! Please visit our website to learn more: www.blusense-diagnostics.com.

We are a highly motivated team of 50+ employees from 20 nations, with offices in Denmark and Taiwan. We have a clear ambition to retain and develop a great work environment and a strong business performance.

Do you want to take part in the generation of next-generation diagnostic devices for emerging infectious diseases? Do you thrive in a dynamic and collaborative international working environment? If yes, apply now!

The job

BluSense Diagnostics is seeking a quality-minded Validation Engineer with strong technical knowledge to join our Qualification and Validation team.

The ideal candidate will work with the Process Validation Specialist on improving the documentation and validation of the current production line, as well as on the process development and validation activities of a new production line. The candidate will work side by side with Senior Engineer/s responsible for the technical process development and will work closely with the R&D and Production department, while keeping strong collaboration with the Quality Assurance department. Ideally, you have previous experience in process development and validation in the IVD medical device/pharma field and are familiar with ISO13485:2016.

Your responsibilities

• Active participation in process development, equipment/facility qualification and process validation activities at BluSense

• Prepare and perform FAT and SAT of production equipment as necessary, in collaboration with production and R&D

• Together with the production department perform assigned equipment IQ, OQ and PQ

• Participate in projects (mainly during design transfer and Launch preparation) as Process Validation SME

• Drive the assigned process validation activities in collaboration with the Process Validation Specialist, the relevant Project manager and Manufacturing Lead

• Ability to effectively interface with the QA department towards the creation /update of production documentation

• Troubleshoots and resolves issues with equipment as it impacts the validated condition/state

• Responsible for providing input, together with the rest of the engineering team, into equipment requirements (e.g. URS) and keeping communication with suppliers

• Support the training of users on the processes within R&D and production

• Improve the procedures for process validation to fulfil internal and external requirements, ensuring validation documentation content is understandable and defendable during inspections and audits.

• Creation and maintenance of Risk documentation (e.g. FMEA) and Process Validation Master Plans and lead related change request processes

• Re-qualification/re-validation activities on current production processes and related documentation

• Reviews protocol (and other document) drafts and resolves circumstances proactively in order to achieve management pre-approval

• Participate in the Change Management process as reviewer/approver of associated Risk assessments

• Support to manufacturing improvements and development as needed

• Ensures that procedures, work instructions, standards maintenance documents or master documents describe critical parameters or ranges determined in validation studies.

• Maintains professional working relationship with co-workers and staff.

Your qualifications

• The ideal candidate will have a technical background (Bachelor Science Degree in an engineering or scientific discipline), preferably with industry experience in medical device production/process development and validation environment

• Relevant work experience within process development and validation in the medical/IVD/microfluidic consumables industry

• Basic computer skills and familiarity with Microsoft Windows, Word and Excel

• Must be familiar with basic laboratory safety, GMP, ISO 13485:2016

• Previous experience in development and validation of a complete production line is considered an asset.

Your personal skills

• Fluency in English, both verbally and strong technical reporting

• Ability to take initiative and have a proactive approach

• Strong attention to detail and problem-solving skills

• Focus on communication with relevant internal stakeholders

• Motivated to continuously learn

• Ability to work in an international environment with cross-functional teams in a fast-paced environment

• Ability to work effectively under pressure to meet established deadlines

• Strong team spirit and enthusiasm

We offer

• Working in a Biotech start-up who wants to make a difference in the world.

• A possibility to form your own job and to contribute across functions.

• Co-operation and exchange of ideas within a multinational and interdisciplinary team of colleagues.

• Professional and personal development and being part of an international high-tech company.

• Easy transport by S-train and free parking.

• Possibility to grow in tasks.

How to apply

Apply ASAP by sending us your CV and cover letter via thehub.com.

Preferably, the right candidate can start ASAP.