Johnson & Johnson Careers
Requisition ID: 4550190121
Johnson and Johnson Sterility Assurance (JJSA) Consumer Medical Device (CMD), located in Santa Ana, CA, is currently recruiting for a Principal Scientist who will be responsible for working on multiple initiatives in support of business/technical objectives in end to end (E2E) Sterility Assurance. The candidate will be a key contact to individual operating companies/business units as a Subject Matter Expert (SME) for Sterility Assurance. In this role, he/she will serve as a project lead for the extended Sterility Assurance team supporting new product /process/packaging development & optimization, and validation of healthcare (Medical Devices and Pharmaceuticals) and consumer products.
DUTIES AND RESPONSIBILITIES:
- Supports the development of new innovations in the areas of aseptic processing and terminal sterilization.
- Supports introduction of innovation into the new product development and new product introduction processes.
- Develops validation protocols and reports for new product qualification and validates products to meet applicable standards.
- Involvement in selection of new manufacturing operations.
- Conducts technical assessments and gap assessments to current and future standards within manufacturing sites and contract sterilization providers/supply chain “supplier activities”.
- Supports the validation strategy for new and existing products.
- Provide technical SME support for procurement activities that relate to sterile or microbiologically controlled products that are externally manufactured.
- Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological and terminal sterilization standpoint.
- Travels to sterilization facilities and test laboratories to oversee sterilization projects and assist in supplier audits as needed.
- Maintain close involvement/alignment with the Research & Development organization to develop technical competencies for future products.
- Work directly with the Technical Vertical JJSA Leaders to find break-through technologies (e.g., for contact lens as drug delivery system).
- Responsibilities will include support to manufacturing and operating companies/business units.
- Partners with QC for environmental monitoring, microbiological testing, investigations or corrective actions, and associated compliance requirements for manufacture of commercial products.
- Support investigations impacting E2E Sterility Assurance including process non-conformances, audit observations, assisting in root cause analysis, and developing robust CAPA and failure analysis.
- Support the ongoing initiatives regarding the validation and improvement of primary sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer.
- Responsible for sterilization related questions from regulatory agencies (FDA, TUV and other associated regulatory agencies), as well as, from internal and external audits.
- Acts as an SME for audits and supplier qualification activities of contract sterilizers and associated testing laboratories.
- Other responsibilities as required or assigned by manager.
- Bachelor’s in Microbiology, Biology, or closely related discipline or 8 years of direct experience preferred.
- A minimum of 8 years related experience is required.
- Expertise in the areas of microbiology, biologics, ethylene oxide (EO), gamma radiation and other gaseous/heat sterilization.
- Excellent familiarity with EN ISO 11135, EN ISO 11137, EN ISO 11138 and EN ISO 10993.
- A strong background with hands on experience in terminal sterilization validation and/or microbiological or laboratory processes.
- Strong knowledge in quality systems and QA compliance as it relates to the sterilization processes and new product introduction.
- Demonstrated ability to develop and deliver instructional training material to the internal and external sterilization community is desired.
- The individual will be a self-starting result-oriented individual with the ability to work independently while also being a productive contributing team player.
- Excellent written and verbal communication skills.
- Ability to work in a matrix environment, with senior level management, and ability to influence and present for multi-disciplinary teams.
- Effective time & program management skills to allow for multi-tasking responsibilities.
- Bachelor’s degree in Microbiology.
- Advanced degree in a biological science discipline.
- Familiarity with reprocessing and re-usable devices.
PHYSICAL WORKING CONDITIONS / REQUIREMENTS:
- This position is located in an office environment and requires frequent meetings and working for extensive periods on a computer.
LOCATION & TRAVEL REQUIREMENTS
- Position location: The primary working location is Santa Ana, CA and other working locations are Raritan, NJ, Jacksonville, Fl or any other CMD manufacturing location.
- Travel required: 40% travel domestic and international.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Ana-
AMO Manufacturing USA, LLC (6240)