Process Engineering and Cleaning Validation Lead
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This role will manage all cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth. The Process Engineering and Cleaning Validation Lead will provide cleaning validation expertise to support the facility start‑up and routine commercial manufacturing. The lead will be responsible for oversight of cycle development and validation of the cleaning processes used within the Drug Substance facility and for ensuring timely and compliant completion of all cleaning validation related activities and milestones.
Organization Description
WuXi Biologics is a premier provider of biologics services from discovery to commercialization with global customers in the biopharmaceutical and healthcare industries. We are one of the world’s top three contract development and manufacturing companies for biopharmaceuticals, offering a world‑leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia and Ireland. We presently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Your Responsibilities
* Manage a team of Wuxi cleaning validation specialists and up to 10 cleaning validation contractors (project dependant). This includes hiring, goal and objective setting, and performance and development management.
* Build and oversee the budgets associated with cleaning validation activities, both Opex (routine) and Capex (project based).
* Own the PEV procedures and plans associated with cleaning validation activities.
* Develop and implement cleaning validation strategies for Clean In Place (CIP) and Clean Out Of Place (COP) systems.
* Oversee the development and optimisation of cleaning CIP cycles/recipes for media, buffer, upstream and downstream equipment trains.
* Oversee the development and optimisation of cleaning COP cycles/recipes for parts washers.
* Work closely with colleagues within the Engineering Department and cross‑functional departments (Manufacturing, QA, Automation and QC).
* Manage the generation and compliance of all cleaning validation documentation, e.g. cleaning risk assessments, cleaning validation protocols and reports and supporting documentation.
* Oversee the process for periodic requalification of validated cleaning processes.
* Collaborate across site functions, global functions and our clients to ensure cleaning validation activities are in line with new product introduction schedules.
* Identify requirements for laboratory studies/trials to support cleaning validation activities and liaise closely with manufacturing/QC to oversee the design and execution of studies (as required).
* Serve as the site subject‑matter expert on cleaning validation activities during regulatory agency and client inspections.
Your Profile
Education
* B.Eng or B.Sc in Chemical / Process engineering or relevant scientific discipline is required.
* A postgraduate qualification in an engineering, scientific or managerial discipline would be advantageous.
* A qualification in project management would be advantageous.
Knowledge/Experience
* A minimum of 8 years cleaning validation experience in addition to a minimum of 3 years’ experience leading teams.
* Extensive experience with cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility.
* Proven people leadership and program management capabilities in a previous role.
* Experience in the execution of commissioning and qualification of process support equipment e.g. CIP SKIDs and parts washers.
* Experience in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing.
* Knowledge and experience with facility start‑up projects (brown field or green field) is advantageous.
* Experience operating in a fully automated Delta V facility.
* Good interpersonal 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.
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!
Join us and reach beyond yourself and discover your true potential. Apply now!
For more information, please visit our careers site or contact talentacquisition@wuxibiologics.com.
WuXi Biologics is an equal opportunities employer.
Seniority level
* Mid‑Senior level
Employment type
* Full‑time
Job function
* Pharmaceutical Manufacturing
Dundalk, County Louth, Ireland
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