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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📌 Process Engineer (pharmaceutical- bioprocess manufacturing science and technology) (Bologna)
🏢 Nessun nome
📍 Bologna