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J&J Family of Companies Scientist Sterility Assurance in Raynham, Massachusetts

6029 - Medical Device Business Services, Inc is currently recruiting for a Microbial Quality and Sterility Assurance Scientist, Product Development located primarily in our Raynham MA site.

The Scientist is responsible for supporting the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products within Global Orthopedics.

This individual will be responsible for activities such as, but not limited to, the following:

  • R&D –

  • Provide input for the following for increasing complexity projects:

  • Design for cleanability

  • Design for decontamination

  • Design for sterilizability

  • Drive selection of sterilization modality, validation approaches and validation of the sterilization process.

  • Generate sterilization product adoptions.

  • Support the regulatory approval of sterile and non-sterile new products, including internal research & development products, new acquisitions, and strategic partnerships.

  • support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing, to include such activities as i participating in development of new products

  • Plan –

  • Provide input into the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third party manufacturers)

  • Source –

  • Provide sterility assurance and contamination control support for due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J

  • Provide sterility assurance and contamination control for procurement activities that relate to sterile, non-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, terminal sterilization and reprocessing standpoint

  • Provide input for the design of critical water and air systems and the design of controlled environments and cleanliness control strategies

  • Provide sterility assurance and contamination control support for supplier audits.

  • Make –

  • Provide sterility assurance and contamination control support to strategic MAKE initiatives

  • Provide input into process risk assessments related to product cleanliness and sterility assurance

  • Lead non-conformance/CAPA pertaining to product cleanliness and sterility assurance

  • Work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance.

  • Provide support to internal and external audits

  • Deliver –

  • Support the ongoing initiatives regarding the validation and improvement of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer

  • Internal Influencing –

  • Participate on the J&J Sterility Assurance Councils.

The Scientist, Sterility Assurance technical areas supported include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.

Qualifications

  • Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility

  • Minimum 2 years experience as a microbiologist in a medical device, pharmaceutical, or similar regulated industry.

  • Knowledge of associated regulations such as US FDA (QSR) regulations and ISO 13485

  • Strong knowledge in competent authority regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred

  • Experience of GMP audits, internal and relevant external audits, would be advantageous

  • Proven knowledge and demonstrated capability of product verification and process validations.

  • Good interpersonal and organizational skills.

  • Comfortable to work with cross functional teams.

  • Excellent communication skills - Written and Oral.

  • Strong attention to detail.

Required Education and Experience:

  • an undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline life science discipline is preferred.

  • a minimum of 2 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required.

  • competent in using computer software such as Excel, Word and PowerPoint, and analytical software.

Supervisor: This position will report into a Sterility Assurance Supervisor or a Sterility Assurance Manager.

Work Environment: The work environment is primarily in a local or remote office, and may require frequent interactions with manufacturing or R&D teams. The individual must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with J&J environmental policies.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location

United States-Massachusetts-Raynham-325 Paramount Drive

Organization

Medical Device Business Services, Inc (6029)

Job Function

R&D

Requisition ID

2206029517W

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