Sr. Cleaning Validation Engineer Role
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As a senior cleaning validation engineer, you will be responsible for leading cleaning validation activities for the manufacture of biological bulk drug substance in a cGMP environment.
You will develop and implement effective cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems, ensuring compliance with EudraLex GMP guidelines.
1. Lead cleaning validation projects for media, buffer, upstream, and downstream equipment trains.
2. Collaborate with colleagues within the process engineering and validation team and cross-functional departments.
3. Author and review cleaning risk assessments, technical protocols, and reports.
Required Skills and Qualifications:
* Experience in cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility.
* Knowledge and experience with facility start-up projects.
* Familiarity with Chromatography and Ultra filtration production operations is desired.
Education and Qualifications:
* BEng or BSc in Chemical/Process Engineering or relevant science discipline is required.
* A postgraduate qualification in an engineering or scientific discipline would be advantageous.
We Value:
* Professionalism
* Respect
* Ownership
* Urgency
* Diversity