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Process Engineer (GMP)
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Design, Engineer
Projektbeschreibung
Process Engineer (GMP)
Period: 12/02/2018 to 11/02/2019
Shore Options Available for this Position: Onshore Only
Killing criteria:
- Experience in manufacturing,
- Pharma process knowledge (GMP),
- EN fluent,
- Communication skills.
Role and main responsibilities:
- Collaborate to the manufacturing development processes by interacting with the design, quality and manufacturing team.
- Contribute to the product development activities by partnering technical scale-up and transfer to manufacturing plants with strong focus on solution aspects of the product
- Deliver robust products and production processes based on Quality by Design and risk-based approach
- Communicate continuously to the team and management any progress/status of the studies under your responsibility.
- Under the guidance of the senior process development staff or project leader but with limited assistance, make sound technical recommendations regarding projects/matters. Provide some analysis/redesign of key experimental procedures.
- Develop appropriate documentation to support development and manufacturing studies.
- Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
- Maintain knowledge of relevant regulatory safety requirements while building knowledge of other regulatory requirements related to R&D (product development, process validation, design and safety) to ensure compliance to the GMP and related regulations and guidance for human medicines.
- Contribute to technical feasibility analysis of complex research and design concepts.
- Maintain technical knowledge on manufacturing processes for various product families, technical platforms and plants. Contribute to technical scale-up activities and transfers to plants.
- Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks. Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.
You may be required to travel to other facilities to support projects execution (up to 25%). Driving license is a must.
Profile:
- Master's degree in Pharmaceutical Sciences, Biomedical Sciences or Chemical Sciences.
- At least 3-4 years of relevant experience
- Knowledge of Pharmaceutical processes (GMP)
- Fluent in English.
- Knowledge of human medicine regulations is an asset
- Knowledge of MS Office (Excel, Word, Outlook, PowerPoint)
- Knowledge of Lean/Six Sigma tools and statistics is a plus
- Possess relevant laboratory/technical, writing, and computer skills
- Effectively able to contribute on a project team and to work in a Matrix organization.
- Demonstrates flexibility and can shift gears comfortably.
- Ability to objectively assess, organize, and clearly communicate complex information.
- Interpret available information and make recommendations to resolve technical challenges.
- Effectively able to work on relevant lab techniques as well as on commercial scale operations.
Period: 12/02/2018 to 11/02/2019
Shore Options Available for this Position: Onshore Only
Killing criteria:
- Experience in manufacturing,
- Pharma process knowledge (GMP),
- EN fluent,
- Communication skills.
Role and main responsibilities:
- Collaborate to the manufacturing development processes by interacting with the design, quality and manufacturing team.
- Contribute to the product development activities by partnering technical scale-up and transfer to manufacturing plants with strong focus on solution aspects of the product
- Deliver robust products and production processes based on Quality by Design and risk-based approach
- Communicate continuously to the team and management any progress/status of the studies under your responsibility.
- Under the guidance of the senior process development staff or project leader but with limited assistance, make sound technical recommendations regarding projects/matters. Provide some analysis/redesign of key experimental procedures.
- Develop appropriate documentation to support development and manufacturing studies.
- Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
- Maintain knowledge of relevant regulatory safety requirements while building knowledge of other regulatory requirements related to R&D (product development, process validation, design and safety) to ensure compliance to the GMP and related regulations and guidance for human medicines.
- Contribute to technical feasibility analysis of complex research and design concepts.
- Maintain technical knowledge on manufacturing processes for various product families, technical platforms and plants. Contribute to technical scale-up activities and transfers to plants.
- Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks. Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.
You may be required to travel to other facilities to support projects execution (up to 25%). Driving license is a must.
Profile:
- Master's degree in Pharmaceutical Sciences, Biomedical Sciences or Chemical Sciences.
- At least 3-4 years of relevant experience
- Knowledge of Pharmaceutical processes (GMP)
- Fluent in English.
- Knowledge of human medicine regulations is an asset
- Knowledge of MS Office (Excel, Word, Outlook, PowerPoint)
- Knowledge of Lean/Six Sigma tools and statistics is a plus
- Possess relevant laboratory/technical, writing, and computer skills
- Effectively able to contribute on a project team and to work in a Matrix organization.
- Demonstrates flexibility and can shift gears comfortably.
- Ability to objectively assess, organize, and clearly communicate complex information.
- Interpret available information and make recommendations to resolve technical challenges.
- Effectively able to work on relevant lab techniques as well as on commercial scale operations.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik