Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)
Italy / South Europe / Full Time
Required experience
- Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert
- Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products
- Process Validation and Continuous Process Verification
- Filter Validation
- Single use manufacturing systems
- Aseptic Manufacturing and Media simulation study
- experience in Technology Transfer team (at least 3 years)
- Experience in project management in Technology Transfer projects or similar context
- Risk management
- Documentation Management (SOPs, Specification, Records)
- Deviations/Non-conformities management
- Data integrity
- use of statistical tools and software
Other Desired Experience:
- experience in biotechnology/ biosimilar products (Cell and gene therapy; Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)
- experience in solid oral pharmaceutical forms
- Product Quality review
- 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
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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