As a Process Engineering and Cleaning Validation Engineer you role will support 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 provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing. The Cleaning Validation Engineer will be responsible for cycle development and validation of the cleaning processes used within the Drug Substance facility. 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.
- Development and optimize cleaning CIP cycles/recipes for media, buffer, upstream and downstream equipment trains.
- Development and optimize cleaning COP cycles/recipes parts washers.
- Work closely with colleagues within the Process Engineering and Validation team and cross functional departments (CQV, QA, Manufacturing, Automation and QC).
- Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required.
- Prioritise cleaning validation activities in line with the project schedule.
- Identify requirements for laboratory studies/trials to support cleaning validation activities and to liaise closely with manufacturing/QC to oversee the design and execution of studies (as required).
- Identify and implement improvements where feasible.
- 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.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Will be flexible to take on additional tasks and responsibilities at the discretion of the PEV Associate Director
- Will act as a role model for the Engineering function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture
Experience
- A minimum of 1-5 years’ experience for cleaning validation engineer role and 3 years’ experience for senior cleaning validation engineer role working in a Biologics or similar GMP environment as part of an engineering, technical services or manufacturing function.
- Experience of cleaning validation for drug substance and/or drug product processing equipment.
- Experience of cleaning validation and cleaning approaches.
- Experienced in the execution of commissioning and qualification of process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
- Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
- Experience operating in a fully automated Delta V facility.
- Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
Knowledge
- Knowledge and experience with facility start-up projects (brown field or green field).
- Knowledge and experience executing cleaning validation studies e.g. spray ball coverage assessments, hold time studies and swab sampling.
- Knowledge and experience of cleaning validation for a multiproduct facility is advantageous.
Qualifications
- B.Eng or B.Sc 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
- Excellent communication, interpersonal and presentation skills.
- Collaborative and inclusive approach to work and your colleagues.
- Excellent problem solving and troubleshooting skills.
- Ability to lead /direct cross function teams and strong project management skills.
- Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
- Engage cross functionally in conjunction with a site-based team.
- Autonomous and a self-starter who will use their initiative to drive actions forward.
- Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations
- Drive a Continuous Improvement Culture within the Engineering 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!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]
WuXi Biologics is an equal opportunities employer.
