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Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

icon building Azienda : Cai
icon briefcase Tipo Lavoro : Full Time

Numero di candidati

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Descrizione Lavoro - Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

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

Disponibilita' trasferte al 100%

La selezione rispetta il principio delle pari opportunità (l. 903/77)

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