Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

Bologna / Milano
EMEA Life Sciences – South Europe /
Full Time /
Hybrid
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

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