Senior Process Engineer
Contract AND Permanent roles available
WuXi Biologics is a global leading biologics services provider that offers comprehensive, integrated and highly customizable services through its teams of scientists, proprietary technology platform and know-how, state-of-the-art laboratories, and cGMP-compliant manufacturing facilities to pharmaceutical and biotechnology companies. The company is the only open-access biologics technology platform in the world offering end-to-end solutions, empowering anyone to discover, develop and manufacture biologics from concept to commercial manufacturing. Its business model is built upon a “follow the molecule” strategy, whereby customers’ demand for the company’s services increases as their biologics advance through development and ultimately to commercialization, which allows its revenue from each integrated project to grow as the project advances
We are to invest €325 Million to Build a biopharmaceutical development and Biomanufacturing Facility Using Single-Use Bioreactors in Dundalk, Co Louth. This state-of-the-art “facility of the future” will be built upon the novel approach WuXi Biologics has pioneered deploying multiple single-use bioreactors for commercial biomanufacturing and is also designed to be able to run continuous bioprocessing, a next generation manufacturing technology to be first implemented globally in this campus. A total of 48,000 L fed-batch and 6,000 L perfusion bioreactor capacity will be installed, representing the world’s largest facility using single-use bioreactors.
WuXi Biologics is building a green-field project for the biopharmaceutical development and manufacturing site in Dundalk, Ireland. This position will be based at Dundalk, Ireland. The occupant will be working as Senior Process Engineer role in Process Engineering and Validation (PEV) department to provide expert technical support to Commercial Cell Culture and Purification Operations and lead major technical initiatives.
This role will be responsible for the full life cycle of the project from concept to completion:
- Liaison with the manufacturing, engineering, QC and QA functions in other sites to define the user’s requirement and transfer the knowledge to the engineering firm and vendors.
- Lead design, build, commissioning and qualification of manufacturing facilities and systems of biopharmaceutical therapeutics. Lead capital and noncapital projects, and process engineering functions insight into the equipment, processes, and operations requirements.
- Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility.
- Lead cross-functional project teams to ensure specific unit operation requirements are implemented and tested in C&Q deliverables.
- Develop and/or review system lifecycle documents including C&Q documentation.
- Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ) readiness
- Ensure all project stakeholders are informed and consulted on key process activities and decisions
- Act as client representative to ensure that critical design deliverables are provided and provide direction & oversee design progression by Engineering Design Team
- Ensure that all relevant engineering standards, procedures and best practices are followed
- Ensure Design Risk Assessments and HAZOPs are performed
After the completion of the capital project, the occupant will be responsible for:
- Network with Manufacturing and Quality organizations to establish a reliable state of process control
- Maintain process knowledge and ownership
- Lead the proposal, initiation, testing and implementation of changes to cell culture and purification processes
- Lead and manage cross functional teams to drive major technical projects and initiatives
- Develop advanced process monitoring programs using a variety of data analysis methods and techniques including multivariate methods
- Develop technical strategies and lead studies to provide a science-based approach for the resolution of deviations, investigations and process issues
- Establish continuous improvement strategies
- Develop strategies for maintaining inspection readiness of the site
- Establish and participate in cross-functional initiatives
- Generate documents (technical memos, protocols, reports, etc.) related to process monitoring programs, studies, annual product reviews and non-conformances.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Act as both SME and project manager to support the design, construction, commissioning, qualification and operation of future Dundalk Ireland facilities of WuXi Biologics
- Lead the process engineering function for Dundalk Ireland facilities
- Support the design, construction, commissioning and qualification of the GMP Facilities
- Support engineering related audit/visit by clients and regulatory authorities
- Ensures that the design, construction, commissioning and qualification of the GMP Facility comply with appropriate regulatory requirement and construction code
- Other duties assigned by management.
- Degree in life sciences, biological engineering, chemical engineering or other relevant degree; BS with 10+ years or Masters with 8+ years or PhD with 6 years of experience
- At least 5 years of experience in a cGMP manufacturing environment or biologics process development
- Experience leading projects and cross-functional initiatives
- In-depth understanding of large scale biotechnology unit operations, principles of biochemical engineering, and process data analysis
- Strives for results and sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets
- Strong knowledge and experience in GMP environment and working within Quality System
- Strong knowledge and experience in project management, ASME BPE, and ISPE guidelines
- Good knowledge and experience in EHS
- Self-motivated with minimum management and Good communications skill
- Proven leadership capabilities in a prior role
- Able to engage and align other stakeholders outside the project team
- Ability to understand and communicate risks and develop and execute contingency plans
- Extensive experience in the operation of large scale biotechnology processes
- Hands on experience with large scale biotechnology unit operations
- Bio-process manufacturing experience is highly desirable
- Proven ability to lead cross-functional and technical teams and align, motivate and empower team members.