Main activities and responsibilities

• Conducting process validation activities on medical devices for product categories  bags for parental nutrition , 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 Radiofrequency 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 2 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