Senior Scientist, Engineering- Analytical Container Closure Integrity; CCI

Job Description

The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, is responsible for physical, analytical & material science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global-human-health portfolio and closely partner with various Packaging or Device Technology engineering groups, packaging sites, and partner analytical groups.

The CPDA is located at our Company’s large research and manufacturing West Point, PA location, where our packaging & device laboratories are established.

Container closure integrity (CCI) is a critical quality & performance attribute across sterile packaging and components—such as vials, pouches, syringes, cartridges or bulk containers. The CPDA is seeking a Sr. Scientist/Engineer who, as an individual contributor, would enjoy focusing on CCI analytical and technical contributions to our packaging and medical device-combination product programs in both late-stage development and supporting global manufacturing.

Projects are diverse and typically include some of the following: (1) characterization of new package or device components to inform selection or optimization; (2) CCI method development & validation; (3) method transfers/lifecycle support; (4) in-depth technical support to resolve packaging and device CCI analytical and manufacturing investigations; and, (5) growing CCI analytical technologies/ capabilities within the CPDA. To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science, be a highly effective communicator (written and verbal) & collaborator on cross functional teams, and, have interest in both long-term strategic technology advancement and personal growth.

• BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as physical chemistry.

• BS/MS with minimum of 5 years or relevant experience in the pharmaceutical, biotechnology, or medical device industries or PhD.
• Familiarity and some experience with CCI testing in either an industrial or academic context.

• Advanced proficiency and understanding of all common CCI technologies, such as dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace, and tracer gas analysis.
• Hands-on CCI test method development, validation, and troubleshooting for packaging and/or medical device products.
• Understanding/familiarity with USP , ISO-13485, and relevant industry standards.

Analytical Method Development, Analytical Thinking, Biomedical Engineering, Biotechnology, Chemical Engineering, Chemistry, Combination Products, Container Closure Integrity Testing (CCIT), Materials Science, Medical Devices, Method Development, Package Testing, Pharmaceutical Industry

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We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City…