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Product Development Engineer Position for Life-Changing Therapeutics
il y a 1 semaine
About Cytiva
Cytiva is a leading provider of solutions to transform human health. Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva, you will be part of a team that works on challenges that truly matter with people who care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
We are proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Job Description
Prepare detailed validation protocols for IQ, OQ, PQ and write the validation reports in close cooperation with quality engineering.
Agree with the engineering technician to get support on tests in manufacturing or engineering lab.
Agree with Design Engineering to create / update product and / or manufacturing drawings while aligning needs for documentation/part setup with Design Engineering Team Leader / Manager.
Build technical documentation such as Product Data Sheets, Training Instructions and Specifications pertaining to the area of expertise.
Managing product changes at resident site to the current portfolio.
You will initiate change requests and work with a team to perform a robust risk assessment by handling the validation of the product and the process change, the customer notification in conjunction with quality and product management and by working closely with supply chain to handle phase-in-phase of the change.
Strong focus on continuous improvement of products and processes;
Apply Danaher Problem Solving Process and use A3 actions plans to tackle standard problems; analyze information and standard practices to make judgments;
Support investigations to resolve customer complaints and complete corrective and preventive actions.
Requirements
You have a Master engineering degree, a Degree in e.g. Mechanical Engineering, Business Engineering, Material Science, Chemical Engineering or equivalent.
You are proficient in spoken and written English.
You have knowledge in process validation procedures and techniques, e.g. Process and product FMEA and process capability studies, plastic processing e.g. seal technologies, injection molding etc.
Preferred Qualifications
2+ years experience of working with large or multinational companies.
2+ years experience in a life science engineering role.
About Us
Danaher is a global leader in science and technology. We partner with customers across the globe to help them solve their most complex challenges. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond.
We value diversity and the existence of similarities and differences found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
