Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

Bologna , Italy
Full-Time
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 Suitable candidates must be available for travel throughout Italy and some European travel may be required. La selezione rispetta il principio delle pari opportunità (l. 903/77) #LI-AG1
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