01 ago - Italia
B. Braun Group
B. Braun is a global leader in medical technology and healthcare solutions, operates in more than 60 countries and employs over 60,000 people worldwide. For the plant of Mirandola B.Braun is currently looking for a Process Enginering Specialist. Main Activities And Responsibilities
Conducting process validation activities on medical devices for product categories empty containers for drugs , as well as on other company assets (cleanroom and sterilization) at our facility and those carried out at external suppliers.
Performing activities related to CSV (Computer Software Validation) and TMV (Test Method Validation).
Basic knowledge of thermical welding , assembling and packaging
Planning and executing tests on the product subjected to process validation when necessary.
Effectively interacting with R&D;, product V&V;, and Operations teams to ensure the maintenance of processes and products according to design and specifications.
Collaborating with design transfer and product industrialization teams to ensure the correct transfer of device design into production.
Knowledge
Degree in Engineering or scientific subjects.
Minimum 3/5 years of experience in the role or similar roles (such as production or validation engineer).
Knowledge of validation strategy and management of validation documents necessary for process validation (IQ – OQ – PQ).
Knowledge of statistical tools: DOE study, Gage R&R;, capacity analysis (Cp, Cpk, Pp, Ppk), definition of sampling size preferably using Minitab software.
Good level of English.
Basic knowledge of project management
Skills
Teamwork
Problem Solving
Adaptability
Critical Thinking
Autonomy
Il presente annuncio si rivolge a candidati di ambo i sessi (L. 903/77). I dati personali saranno trattati ai sensi del GDPR (Regolamento Europeo 2016/679). Sede di lavoro Mirandola (MO)
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