Looking for an exciting job in Puurs? Do you have a degree in Mechanical, Chemical, or Pharmaceutical and at least 5 years of experience? Do you have a good knowledge of cGMP requirements and compliance? Do you describe yourself as communicative? Don't hesitate to contact us!
If you can start in this position you will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.
Within the global supply - sterile injectable technology branch, we are looking for a highly experienced profile who will follow up the entire product life cycle of aseptic products. This also includes co-development, technical transfers, scaling up, process validation, registrations and troubleshooting.
The person ends up in a team of 8 people, each of whom has an expertise. There is formulation, preparation, aseptic filling process and freeze-drying. Because it is a global department you come into contact with Procurement, Quality, GCMC, R&D, ..
- Being subject matter expert and able to give advice as well as offer solutions to problems that can be complex -> vaccinations / sterile injectables / biologicalL
- Assisting with the complete documentation
- Participation in co-development process, (phase 3 clinical supply) to commercialize and further provide product support
- Use technical knowledge at business level
- Prepare, review and approve documents (protocols, reports, technical assessments, study plans)
- Collaborate with other labs (Wet chemistry & analytical chemistry)
- Maintain monthly project updates
- Risk analyzes and discover problems
- Using DMAIC principles in daily work
- Masters with minimum of 5+ years or Bachelors with minimum of 7+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
- A strong operational or engineering background in Drug Product operations is a requirement; experience as a Drug Product expert is definitely a plus
- Knowledge of cGMP requirements and compliance
- Excellent communication and technical writing skills; very good knowledge of English required
- Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
- Ability to think creatively and find innovative solutions is a plus
- Good communication and project management skills are needed
- A balanced salary package based on your capabilities and experience.
- Existing right to work in Europe required.
Vacancy number : 18224