Engineering · Full-time · Bologna, Italy
Agent expected skills: Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on): - Technology Transfer: at least 4/5 years of experience in a TT team as Process Technology SME (alias process Manufacturing Science and Technology/Process Engineer) or Process Validation SME - Experience in project management in TT projects or similar context - Management or involvement in an average number of TT projects (not less than 5 ) - Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products Cleaning Validation experience
Other Desired Experience: - Developing Validation / Verification Master Plans - Performing formal risk assessments / FMEA - Change Control - CAPA process - Identifying Critical Attributes and Critical Process Parameters - Commissioning and Qualification - Developing User Requirements - Schedule development and execution - Establishing metrics and leading team to achieve performance goals - Facilitating meetings La selezione rispetta il principio delle pari opportunità (l. 903/77) #LI-AG1