For a partner in France (near Basel - Switzerland) we are looking for a Cleaning Validation Engineer.
- are experienced in Cleaning Validation for Biotechnology Industry
- are fluent in French and English
- know the cGMP regulations
You... can check all of the above bullet points?
Then don't hesitate and apply now!
Preparation of Cleaning Validation activities related to the installation of all new equipment during SCALE Project.
- Execution of the following activities for the relevant systems in accordance with procedures/guidelines :
- Evaluation of Cleaning Validation: includes update or creation of Cleaning Validation Risk Analysis in accordance to the site strategy, definition/verification of cleaning verification flow path, cleaning cycle description...
- Preparation of Cleaning validation: includes updates or creation of Cleaning Validation protocol in accordance to the site strategy
- Preparation of Cleaning validation execution: includes updates or creation of Cleaning Validation forms for sampling, sampling plan, analysis form, SAP setup...
- Participate in sessions to define & agree on work & strategy to apply for SCALE Cleaning Validation scope and priority with respect to the relevant systems
- Report key deliverables and dates & align with key milestones within the project’s critical path.
- Report and aid in the resolution of project issues
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
- Coordination and communication with other site personnel for Cleaning validation matters.
- Senior Engineer
- Experience in Cleaning Validation for the Biotechnology industry
- Fluent French and English language written and verbal communication skills.
- cGMP knowledge and knowledge of EMA and FDA predicate rules.
- Basic Biopharmaceutical knowledge.
Anneleen De Vos
+32(0)15 21 11 04