As a Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth. The Cleaning Validation Engineer will validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. The position is accountable for timely completion of cleaning validation related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.
Essential Duties and Responsibilities
- Develop and implement cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems.
- Ensure following EudraLex GMP guidelines.
- 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 cleaning risk assessments, technical protocols and reports and supporting documentation as required.
- Own the PEV procedures and plans associated with cleaning validation activities.
- Prioritise cleaning validation activities in line with the project schedule.
- Implement product change over assessments.
- Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required).
- Identify and implement improvements where feasible to cleaning processes.
- Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale.
- Temporary shift working may be required during periods of engineering batch and validation batch execution.
- Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations.
- Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the Process Engineering and Cleaning Validation Lead.
- Will function as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Technical Competencies
- Experience of cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility.
- Experience in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing.
Experience
- A minimum of 8 years cleaning validation experience leading cleaning validation programmes in multiproduct facilities.
- Knowledge and experience with facility start-up projects (brown field or green field) is advantageous.
- Experience operating in a fully automated Delta V facility.
- Excellent communication skills including computer literacy and ability to work independently and in a team.
- Thorough knowledge of current Good Manufacturing Practices (cGMP).
- Familiarity with Chromatography and Ultra filtration production operations is desired.
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.
- A qualification in project management would be advantageous.
Behavioural Competencies
- Strong leadership competencies with demonstrated management skills.
- Good people skills coupled with demonstrated ability to collaborate effectively across functions and sites.
- Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Engage cross functionally in conjunction with a site-based team.
- As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!
