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Media/Buffer Manufacturing Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineering
Projektbeschreibung
MEDIA/BUFFER MANUFACTURING SPECIALIST
Our global pharmaceutical client based in central Switzerland are currently undertaking a new build project of a high-spec, automated facility of the future. They are building the project team and need experienced and confident individuals to support.
Role and Responsibilities:
- Support the manufacturing team in the preparations for the construction of the new biotech facility. Provide expertise in the area of media and buffer preparation processes.
- Oversee and coordinate the preparation of relevant project documentation relating to media and buffer equipment including URS, design documentation, communication with suppliers and validation strategy.
- Provide technical input and knowhow based upon knowledge and experience of the biopharmaceutical industry, specifically media and buffer equipment.
- Support the development of manufacturing processes relating to media and buffer equipment including communication with engineering, QA and automation teams; daily business and validation processes.
Requirements:
- Strong experience within a manufacturing or production team and excellent grasp of production processes.
- Excellent knowledge and experience with media and buffer equipment, processes, ways of working and regulatory requirements.
- Experience with greenfield/new build or large CAPEX projects within a GMP regulated environment beneficial.
- Excellent understanding of best manufacturing practices and documentation requirements for FDA and GMP.
- Outstanding communication skills, and previous experience working in interdisciplinary teams and reporting to senior management teams.
- Fluent German language skills essential, some English language knowledge required.
Our global pharmaceutical client based in central Switzerland are currently undertaking a new build project of a high-spec, automated facility of the future. They are building the project team and need experienced and confident individuals to support.
Role and Responsibilities:
- Support the manufacturing team in the preparations for the construction of the new biotech facility. Provide expertise in the area of media and buffer preparation processes.
- Oversee and coordinate the preparation of relevant project documentation relating to media and buffer equipment including URS, design documentation, communication with suppliers and validation strategy.
- Provide technical input and knowhow based upon knowledge and experience of the biopharmaceutical industry, specifically media and buffer equipment.
- Support the development of manufacturing processes relating to media and buffer equipment including communication with engineering, QA and automation teams; daily business and validation processes.
Requirements:
- Strong experience within a manufacturing or production team and excellent grasp of production processes.
- Excellent knowledge and experience with media and buffer equipment, processes, ways of working and regulatory requirements.
- Experience with greenfield/new build or large CAPEX projects within a GMP regulated environment beneficial.
- Excellent understanding of best manufacturing practices and documentation requirements for FDA and GMP.
- Outstanding communication skills, and previous experience working in interdisciplinary teams and reporting to senior management teams.
- Fluent German language skills essential, some English language knowledge required.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges