Aseptic Processing Specialist Job

Job description

Aseptic Processing Specialist-5330150113DescriptionJohnson & Johnson Services, Sterility Assurance is recruiting an Aseptic Processing Specialist to be located in Raritan, NJ.Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Aseptic Processing Specialist will be responsible for simultaneously working on multiple initiatives in support of business/technical objectives in aseptic processing. The candidate will be a key contact for individual manufacturing sites and operating companies. The Specialist is responsible for and has authority to perform the following tasks/functions: In this role, he/she will provide direct support to the extended Sterility Assurance team in the aseptic manufacturing of new product / process / packaging development & optimization, and validation of healthcare (medical device and pharmaceuticals) and consumer products. In addition, he/she will provide direct support to the extended sterility assurance team in the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment and controlled manufacturing environments (CME’s) used to aseptically manufacture healthcare and consumer products.
Other responsibilities of the Aseptic Processing Specialist will include direct support to operating companies in gap analysis and root cause investigation of routine process failures, training and consultation as well as in assessing and improving regulatory inspection readiness. In addition, this individual may be required to provide hands-on support for aseptic processing or sterilization of components at internal or external manufacturing sites. This individual will be responsible for conducting technical assessments (both internal and at external manufacturing providers). Collaborate with the groups thought leader and individual contributors in the design of experiments, recommendations for process development-optimization, and validation. Support the operation and maintenance and operation of terminal sterilization equipment at Johnson & Johnson Sterility Assurance.
QualificationsBachelor’s degree in the Sciences, Engineering, Microbiology or a related bachelor’s degree and 5 years of related experience is required. Working knowledge of the aseptic manufacturing of healthcare medical devices, pharmaceuticals or and consumer products is required. Experience working in a controlled manufacturing environments such as; clean rooms, Restricted Access Barrier Systems (RABS) or isolators is preferred. Experience in conducting or assessing container/closure test methods for maintenance of sterility preferred. Hands on experience with the validation and qualification of equipment associated with the aseptic manufacturing process including moist heat and vapor hydrogen peroxide (VHP) sterilization is preferred. Hands on experience with bioburden monitoring and environmental controls including trending and failure investigation is preferred. Being knowledgeable in quality system activities and QA compliance for change control, calibration, preventative maintenance, data analysis, and documentation is preferred.
The individual will be a self-starting results oriented individual with the ability to work independently while also being a productive contributing team player. Have excellent written and verbal communication skills. Ability to work in a matrix environment, with senior level management, and ability to influence and present sensitive information to all levels of the organization is required. Effective time management skills to allow for multi-tasking of responsibilities.
This position will require up to 50% travel domestic and international.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NAJ2W: BIOPrimary Location:North America-United States-New Jersey-RaritanOrganization: Johnson & Johnson International (6078)Travel:Yes, 50 % of the TimeJob Function: R&DCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement