Process Engineer
4 giorni fa
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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