Packaging Engineering Fellow – Johnson & Johnson – Raritan, NJ, USA
The Senior Principal Packaging Engineer position will enable Enterprise Standardization of the design, validation and execution of the Packaging Process, Technologies, Equipment and Operating Practices to cost effectively and efficiently meet customer regulatory requirements.
This role will develop standards that meet the requirement of all these bodies and apply that as the gold standard and we have the best validation with best regulatory measurement required.
This builds functional expertise and competency with maturity to deliver a process that is best in class.
Develop and implement packaging standards across the Janssen network working in conjunction with the J&J Packaging CoEs. (Equipment, Materials/Components, Testing, Processes)
Lead the development and standardization of packaging processes such as Packaging Technical Transfers,
Design of Packaging Components, Packaging Validation, cold chain, distribution, packaging related investigations and CAPAs.
Act as the Packaging Science Subject Matter Expert (SME) to the GTS organization supporting Global Supply Chain.
Provide Technical engineering and validation expertise for the design, development, testing, qualification, and implementation of packaging equipment and/or packaging materials and processes across all manufacturing sites.
Lead the Packaging Information Hub providing daily support to the J&J Packaging CoE’s and their customers across J&J.
Support as the Packaging Material SME to quality or compliance investigations for Janssen.
Directs packaging material suppliers to new areas of innovation and responsible for driving the development of new technology to resolve packaging related issues.
The successful candidate will possess excellent communication skills and will be capable of interacting with all levels within a multi-location organization. The ability to think broadly and facilitate cross-functional team’s investigations and/or programs representing J&J and Janssen is required.
A minimum of 15 years’ experience working on complex projects/programs along with a working knowledge of packaging processes within R&D or packaging manufacturing and/or engineering, and GMP compliance in the Pharmaceutical or Biotechnology industry is required.
A minimum of a PhD degree in Packaging Material Sciences or equivalent is required.
A BS/MS in Chemical, Mechanical or Industrial Engineering is desirable.
Pharmaceutical, OTC or Medical Devices Packaging Supply chain knowledge is required.
Packaging Technical Transfer knowledge as either R&D lead or project manager for new products for multiple packaging technologies in solid dosages forms, parenterals or biotechnologies including devices or combinations products is required.
Packaging R&D and Packaging Engineering Design including but not limited to primary, secondary and tertiary packaging components design is required
Strong knowledge of packaging processes for medical devices and/or combination products requirements such as Design Controls, Design Validation and Human Factors Studies is highly desirable.
Quality and regulatory experience supporting new product submissions and launches in the pharmaceutical or Biotechnology industries is preferred.
Cold chain and distribution experience is highly desirable.
Quality systems expertize leading and providing scientific support for packaging investigations as the Packaging Materials SME is required.
Excellent written and communication skills and scientific technical writer, publication, or presenter is preferred
Competency in use of business and project management computer software is required.
Working with External organization and groups is required.
This position will average 30-40% travel both domestic and international.