- Manage cleaning activities on a daily support basis for CDMP/CDOP, including investigation analysis and corrective action handling.
- Manage cleaning and write cleaning procedures, protocols, and reports. Control changes via change management process and principles.
- Manage all aspects of introduction of an NPI in the plant in close collaboration with the Pilot Plant operator, engineer and manager, Scientific Integrator (SI), Analytical method development group,... e.g. requesting/gathering data (solubility, PDE, MBO,...), initiate development of new analysis methods, calculate carry-over limits etc.
- Where needed, develop and model new cleaning methods for existing equipment or for the introduction of new equipment.
- Manage the equipment cleaning validation master plan and make sure that validations and verification runs are executed on time, right first time.
- Identify and lead cleaning improvement projects related to speed, quality, compliance, environment, safety of existing cleaning methods.
- Maintain the highest standards in quality and compliance in assuring patient safety; maintain highest standards in operational safety.
- Back-up for cleaning expert CDPP in Geel.
qualifications - Scientific master degree in Chemistry, Engineering or Bio-Engineering, or equivalent by chemical operations/development experience.
- Strong interest and preferably experience in working in a chemical operational development environment. This means short timelines, high flexibility in combination with high accuracy.
- Knowledge of GMP is required; experience in cleaning validation is preferred.
- Strong technical interest in API synthesis equipment and strong administrative and documentation skills.
- A strong safety, quality, and compliance mindset is required.
- Successful candidate must be able to demonstrate strong cross-functional collaboration, strong communication and negotiation skills and work efficiently both individually and in a team.
- Project management experience is a strong asset (e.g. process excellence, lean principles). Candidate must show good organization skills, capable of handling multiple projects.
qu'offrons-nous You can fill this position through Randstad Professionals as a consultant In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as - Gross salary according to your experience
- Lunch vouchers of €7 per day worked
- Net remuneration of €80 per month
- Company car with fuel card (subject to conditions) or Mileage allowance
- Hospitalisation insurance
- 1 extra day's holiday per month worked
- End of year bonus
- Pension Plan
- ECO vouchers worth €250 (on an annual basis, pro rata)
- Training opportunities
Cleaning Expert Validatie - Beerse, België - Randstad
Beschrijving
The Chemical Process Research and Development (CPRD) department is seeking a Cleaning Expert to join our team in Belgium.
Within the CPRD, we have three state-of-the-art pilot plants in Beerse and Geel which support the development of new chemical processes and produce Active Pharmaceutical Ingredients (API's) used in clinical trials. In Beerse, we have the Chemical Development Mini Plant (CDMP) with small batch reactors and solid/liquid separation, drying and milling technology and the Chemical Development Oligonucleotides Plant (CDOP) where we can support synthesis and processing of oligonucleotides. In Geel, we have the Chemical Development Pilot Plant (CDPP), where we have larger batch reactors for clinical and commercial API production. The pilot plants are constantly innovating the technology and data infrastructure to increase flexibility and end-to-end productivity for future product and development needs.
responsabilités
For the 2 API Pilot Plants in Beerse (CDMP and CDOP) we are looking for a Cleaning expert.
As Cleaning Expert you support the first introduction of new processes in a GMP plant environment. You act as subject matter expert for cleaning introductions and guard the patient safety via the overall cleaning status (validation/verification) of CDMP and CDOP.
Responsibilities: