Contract: Temporary for 1 year with the possibility of extension
Languages: Dutch and English
Our client is a world leader in healthcare and creates medicines, vaccines, and biological therapies. They provide support services and innovative treatments for better health of people and animals in more than 140 countries. They are actively involved in improving access to healthcare through extensive policies, programs and partnerships.
Your main responsibility as a Commissioning and Qualification Engineer will be to lead and oversee the delivery of qualified systems and monitor their performance.
- Lead the validation process and oversee validation activities of third parties
- Apply Lean Six Sigma and Lean methods
- Create and carry out validation studies for the large scale API processes
- Collaborate with stakeholders, quality control/assurance or quality operating systems
- Prepare, assess and approve technical documents, CAPAs, deviations, change control for API processes, etc.
- Follow and communicate developments in the validation guidelines
- Degree in Mechanical, Chemical Engineering, Food Technology, (Bio)Chemistry, Biotechnology, or equivalent
- Good communication in Dutch and English
- 3-5 years of experience in the pharmaceutical/biotech in a role similar to Quality Validation
- Good writing skills
- Communicative and attentive to details
- Sterile manufacturing C&Q experience a plus
- Experience with Computer System Validation is a plus