Job Opportunity
We are seeking a highly skilled Senior Process Engineering and Cleaning Validation Professional to join our team.
The successful candidate will play a key role in leading cleaning validation activities for the manufacture of biological bulk drug substance at our facility.
This position requires strong leadership competencies, excellent communication skills, and a thorough knowledge of current Good Manufacturing Practices (cGMP).
Key Responsibilities:
* Develop and implement effective cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems.
* Evaluate adherence to regulatory guidelines, such as EudraLex GMP.
* Lead cleaning validation projects for media, buffer, upstream and downstream equipment trains.
* Collaborate closely with colleagues within the Process Engineering and Validation team and cross-functional departments (QA, Manufacturing, Automation and QC).
* Author and review technical protocols and reports, including cleaning risk assessments and supporting documentation.
* Prioritize cleaning validation activities according to project schedules.
* Implement product change-over assessments.
* Identify requirements for laboratory studies/trials to support cleaning validation activities and consult closely with manufacturing/QC to oversee study design and execution.
* Identify opportunities for improving cleaning processes and lead their implementation.
Requirements:
* Experience in cleaning validation for drug substance and/or drug product processing equipment in multiproduct facilities.
* Expertise in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing.
* A minimum of 8 years' experience in cleaning validation, with a track record of leading cleaning validation programs in multiproduct facilities.
* Familiarity with facility start-up projects (brown field or green field) is advantageous.
* Experience operating in fully automated Delta V facilities.
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 beneficial.
* A qualification in project management would be advantageous.