Beschreibung
Optimus Life Sciences are working with a Global Engineering & Consulting Company, together we are looking for a Cleaning Process Validation Consultant to be based onsite at one of their clients in Frankfurt, Germany.
This opportunity will be through a consultancy completing Cleaning Process Validation tasks, working at onsite at their CMO Client.
Senior Cleaning Process Validation Engineer
Frankfurt, Germany - 6/12 Month Contract
Key responsibilities;
- Strong experience writing and developing Cleaning Process Validation Protocols.
- Ensuring process validation is conducted within FDA, Site and Local Guidelines.
- You will need to help develop and maintain validation program documents including SOPs and Master Plans (VMPs).
- You will lead the development and execution of process validation studies, data analysis and final reports eg hold studies, resin lifetime etc.
- Lead the development and execution of engineering studies in support of PV eg Mixing studies, Resin Blank Runs etc.
- Ensuring compliance related to validation activities with other groups to meet established validation policies and procedures and cGMP requirements
Ideal candidates will have;
- 5+ years' operational validation experience in a Pharmaceutical/Biotechnology environment.
- Previous CMO experience will be highly beneficial.
If you are interested, please contact me for more details.