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Senior Associate Engineer, Recipe Process Development
Requisition ID: 00001BYA
Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring a Senior Associate Engineer, Recipe Process Development to be based out of Spring House PA, Malvern PA, Cork Ireland, or Beerse Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Responsible for the implementation and ownership of recipe based standards and technology systems within the Pharmaceutical Drug Development and Manufacturing Sciences (PDMS) for the Janssen R&D Operations organization.
- Responsible for development and implementation of a Recipe based Development Process (ANSI/ISA-88 standard) throughout the PDMS organization including development of key software solutions for authoring, life cycle management, scaling, transformation, and exchange of product/platform recipes.
- Responsible for key deliverables associated with data management strategy in PDMS, including critical data pipelines driving recipe based data management and enterprise alignment.
- Key elements of the role include teamwork and partnering with global stakeholders, in both PDMS and the Janssen Commercial Supply Chain organizations.
- Ensure overall compliance with regulatory requirements and GxP, as related to knowledge management.
- Business owner responsibilities for strategic laboratory and manufacturing data management systems within PDMS. Serve as a liaison between IT and the system users in the PDMS organization supporting system enhancements, changes, upgrades, troubleshooting, and other base activities.
- Manage relationships with vendors for key laboratory, manufacturing, and data analytics systems.
- Maintaining Subject Matter Expertise in scientific and process engineering big data management through participation in industry meetings, workshops, and academic collaborations
- A minimum of a Bachelor’s degree in a Technical or Scientific discipline such as Engineering, Life Sciences, Information Technology, Management Information Systems, Manufacturing Execution Systems Computer Science and a minimum of four (4) years of related work experience is required.
- A minimum of two (2) years of expertise in Pharmaceutical or related regulated industry is required.
- Recipe Development authoring experience is required
- Basic knowledge of Process Engineering (development, scale-up, optimization, and technology transfer) is required.
- This position can be based out of Spring House PA, Malvern PA, Cork Ireland, or Beerse Belgium and requires a minimum on 15% travel internationally and/or domestically.
- ANSI S88/S95 standards experience is highly preferred.
- Experience or knowledge of Manufacturing Execution Systems (MES) Systems in support of pharmaceutical process development and/or clinical manufacturing required is preferred (development, testing and validation, recipe authoring) is preferred.
- Experience with Management Information Systems (MIS) Systems is preferred
- Experience working within a GxP environment, implementing and maintaining high quality standards for all aspects of the work conducted including adherence to regulatory and GxP compliance, as they pertain to data management and software development is preferred.
- Basic knowledge of applied statistics (ex: DOE) or experience with advanced data analytics is preferred.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Spring House
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)