pIn billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million. Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a... /p h3Senior Quality Engineer – Microbiology, Sterility Contamination Control /h3 pTo strengthen our global Quality organization, we are looking for a Senior Quality Engineer – Microbiology, Sterility Contamination Control. In this highly visible role, you will act as the global Subject Matter Expert (SME), shaping and advancing our approach to microbiological quality, sterility assurance, and contamination control throughout our manufacturing network. This is a unique opportunity to make a meaningful impact on product quality, regulatory compliance, and ultimately patient safety. You will drive the development and continuous improvement of robust strategies, programs, and systems covering microbiological testing, sterility assurance, and contamination control across products, manufacturing processes, sterilization technologies, and supply chain activities. Working closely with colleagues in Quality, RD,



Manufacturing, Engineering, Regulatory Affairs, and Operations, you will establish best practices, provide expert guidance, and help ensure alignment with international regulatory requirements. /p h3Key Responsibilities /h3 ul liLead and continuously improve Datwyler Healthcare's global Contamination Control Strategy (CCS) in line with EU GMP Annex 1 requirements. /li liDrive microbiological risk assessments and define effective contamination prevention measures. /li liProvide technical leadership on microbiological testing, including bioburden, endotoxin, and sterility-related methods. /li liDefine and oversee environmental monitoring and cleanroom control strategies across manufacturing sites. /li liDevelop and maintain global sterility assurance approaches for pharmaceutical primary packaging components. /li liSupport validation of sterilization, cleaning, washing, and packaging processes. /li liLead complex microbiological investigations, root cause analyses, and CAPA activities. /li liPartner with cross-functional teams to drive quality improvements and ensure regulatory compliance. /li /ul h3What We’re Looking For /h3 ul liMaster's degree or PhD in Microbiology, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, or a related scientific discipline.



/li liMinimum 10 years of experience in the pharmaceutical, biotechnology, medical device, or primary packaging industry. /li liStrong expertise in sterile manufacturing, sterility assurance, contamination control, and process validation. /li liSolid understanding of GMP requirements, including EU GMP Annex 1 and Quality Risk Management principles. /li liProven ability to provide scientific leadership and influence stakeholders across a global organization. /li liExcellent communication and collaboration skills. /li liFluent in English, any other language is a plus. /li /ul h3What We Offer /h3 ul liAttractive compensation package that rewards your expertise and impact. /li liFlexible working arrangements with hybrid options to support a healthy work-life balance. /li liContinuous learning and development opportunities to help you grow your skills and advance your career. /li liThe chance to work with cutting-edge technologies across exciting, fast-evolving industries. /li liA collaborative, high-performing team environment where your ideas and contributions truly make a difference. /li /ul h3Be yourself at Datwyler /h3 pWe are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas. /p #J-18808-Ljbffr

📌 Senior Quality Engineer - Microbiology, Sterility & Contamination Control (Pregnana Milanese)
🏢 Datwyler Group
📍 Pregnana Milanese