As a key member of Engineering and Facilities Management Team, the Associate Director of AIS and GMP e-Systems is responsible for working with Site and Global Engineering Leadership in two areas:Automation that includes process, building, environment monitoring and package unit automation;Global GMP e-Systems which includes quality control laboratory and quality assurance computerized systems.
Also, this individual will lead the execution of biopharmaceutical facility engineering design, including all instrumentation / control / integration activities. This role will build and develop the / automation and GMP e-System team to support the facility day-to-day. The successful candidate will have effective communication internally and externally to ensure (a) the alignment of site with global AIS and GMP e-Systems strategies and (b) the alignment of site automation and deployed enterprise GMP e-Systems with WuXi Biologics global facility / GMP e-System technical, quality and regulatory strategies and the industry best practices in the region.
This role initially will report to the Project Director until the Worcester capital project is completed and will then transition to report to the Site Engineering Director. A successful candidate will have both capital project and plant operational expertise. Both are required as the site transitions from project-based to site-based sustaining operations.
Capital Project Functions
- Work with the local Site and Global Engineering Leadership, various internal function teams across the WuXi Biologics organization, and 3rd party contractors to lead the activities to implement automation solutions and to deploy global GMP e-System enterprise quality and lab applications for a new clinical / commercial biologics manufacturing facility.
- Drive functional commitment on the project and provide high level of oversight and coordination to seamlessly integrate automation engineering efforts within the site.
- Ensures that the deployment and local qualification / acceptance of site automation and the enterprise GMP e-Systems are aligned with global strategy and standards and that deployed systems comply with appropriate quality and regulatory guidance.
- Provide leadership and align site activities with global practices as needed to ensure successful deployment of GMP e-Systems to the site. Systems include: LIMS, CDS, ECM (instrument raw data file archiving), quality management, document control, training management, asset management and calibration / maintenance management.
- Works with site and global Business Process Owners to ensure design of site business processes are aligned with global process and GMP e-System global design. Ensures adoption of global GMP e-System SOPs. Establishes local SOPs and processes aligned with global standards and / or recommendations as needed.
- Proactively documents, tracks and communicates project status including problem areas. Ensure work is completed in the required timeframe and within budgetary requirements.
- Provide budget, work order, change order proposals with justification in relation to site automation and GMP e-System activities and global governance, and following established procedures to apply effective cost control of those activities with best practice and efforts.
- Conduct effective communication internally and externally to ensure alignment with Site and Corp objectives in responsible function area(s)
Sustaining Site Functions
- Supports cGMP manufacturing of both clinical and commercial products and provides automation and GMP e-Systems support for the initial facility build out, CDMO technology transfers and future capital projects.
- Responsible for leading the day-to-day automation and GMP e-System local business support activities by establishing and ensuring required site key user roles for each application are adequately staffed and personnel in those roles are adequately trained. These roles will ensure smooth site operations by providing business process and e-system functional usage subject matter expertise to site end users and by participating in GMP e-Systems global technical support processes.
- Lead site activities, coordinate with site and global teams to govern computerized system lifecycle management in accordance with computer system validation, data integrity and company processes for IT service management.
- Actively participate in GMP e-System global governance processes with other sites and system owners to provide feedback on system issues, present ideas for potential process or system enhancements and to ensure site usage of enterprise systems conforms to global agreed standards.
- Responsible for the day-to-day automation, programming and data maintenance and support from including but not limited to facility utility/equipment maintenance/trouble shooting, PM/calibration, operational safety, etc.
- Establish site good automation practices (user requirement specifications, engineering/design specifications, naming/tagging procedures, project-to-owner turnover procedures, engineering documentation and changes, etc.)
- Ensure potential safety hazards are identified/shared and effective corrective actions are rapidly implemented.
- Develop and approve documents related to automation and GMP e-Systems site management; SOP's, Work Plans, Job Aids, Various Policies and Procedures, etc.
- Support various operation functions for deviation investigation, CAPA implementation from automation perspectives as needed, and engineering/validation related audit/visit by clients and regulatory authorities
- Ensure the development of detailed project plans and timelines including resource and equipment needs, budgets, outside contractors, purchased equipment and materials, etc.
- Build, lead and develop a team of full time and contract automation engineers and quality system engineers to accomplish these goals.