Associate Director
vor 4 Wochen
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are looking for a **Digital Transformation Workstream Lead for the Vibe-X Program (M/F/d)** for the first manufacturing facility combining Bioconjugation and Microbial Technology in one asset for **our location in Visp** Your main area of responsibility will be the digital product ownership and specifically being the main point of contact to define and implement the data exchange with the customer. This includes on one hand, the project coordination of local and global experts in Quality, Manufacturing, MSAT and IT for defining the requirements as well as solution design establishing a smooth data exchange with our customer during the ramp-up and on the other hand being the lead of the operations internal data digitalization/visualization. The program needs to follow a global architecture and standards for data exchange but consider Visp and Program specific requirements. Other responsibilities include to capture and defining the evolving requirements for data capture based on the current and future scientific needs of the project, and ensuring that the standards are maintained and evolve according to the needs and in compliance with Lonza standards. You will also ensure that data is accessible to all project stakeholders, and to support the development and execution of Lonza's innovation strategy; whilst demonstrating strong network/expertise with other global data management roles within Lonza.
**What you’ll do**:
- Taking over the project and product lead for the digital workstream to establish the data exchange platforms according to the customer needs of the entire customer program.
- Act as the main point of contact for all stakeholders within the project and against the customer to ensure the data transfer via LIMS, SAP and MES.
- Accountable for ensuring the business perspective of the site is understood and met by Lonza’s standard computerized system.
- Collaborates with key stakeholders to gather user requirements for process data track and trending.
- Leads project meetings at established frequencies and is accountable for successful project execution.
- Defining details requirements and a backlog to implement Lonza’s standard data taxonomy and architecture enabling standardized data access, data trending, process monitoring, process investigations.
- Act as the Data Steward as defined in Lonza’s SOPs and ensure data owners exist for the key computerized system of the program to ensure it is available for the projects objectives (e.g. takes raw data, transforms it and stores it in formats appropriate to the use cases.
- Review assessment/audit reports, respond to findings, and take appropriate actions to ensure business processes are in compliance with GxP requirements.
- Responsible for periodic review of the solution as defined in the system-specific SOP.
- Ensure that a local procedure is available for the business continuity.
- Is accountable for answering requests from inspectors/auditors during regulatory Inspections and customer/internal audits.
- Ensure the generation/review/approval of validation documents together with local QA and the global CSV team
- Performs other job tasks as defined by line manager.
**What we’re looking for**:
- Bachelors’ Degree or equivalent in an engineering discipline (biomedical, chemical, biochemical, etc.), or a life science equivalent. A Master’s degree in a related field is a plus. Computer/database background is acceptable.
- Strong knowledge of Statistical Process Control and Continuous Process Verification.
- Understanding of large-scale biotechnology unit operations and GMP requirements.
- Strong leadership skills, capable of distilling complex analyses into easy to understand presentations.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management and stakeholders.
- Clear and effective verbal and written communication.
- Displays a clear willingness to listen to others. Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives.
- Shows commitment and dedication and strives to be ahead of schedule.
- Demonstrates ability to find creative solutions to issues and obstacles.
- Practices safety awareness at all times and considers impact of actions prior to performing activities.
- Familiar with LIMS Sample Manager, MES Syncade and SAP.
- Strong computer skills (including Word, Excel, Outlook and PowerPoint.), data systems and data analysis.
- Demonstrates critical thinking skills in problem-solving and decision making.
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