Senior Scientist, Microbiological Quality and Sterility Assurance Product Development.

Job content

Johnson & Johnson, Medical Device Business Services, Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Scientist, Microbiological Quality and Sterility Assurance Product Development. This position can be located in Raynham, MA; West Chester, PA; Warsaw, IN; or Zuchwil, Switzerland. Remote locations within the United States and Europe may be considered.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Senior Scientist, Microbiological Quality and Sterility Assurance (MQSA) Product Development, will be responsible for supporting the end-to-end development of new products and sustainment of commercial products within Global Orthopedics.

Principal Responsibilities

Research and Development (R&D):

• Provide input for the following for complex projects:
• Design for cleaning
• Design for disinfection
• Design for sterilization
• Drive selection of sterilization modality, validation approaches and validation of the sterilization process.
• Lead, manage and develop sterilization product adoption assessments.
• Support the regulatory approval of sterile and non-sterile new products, including internal R&D products, new acquisitions, licensing, and strategic partnerships.
• Support the implementation of new innovations in the areas of microbiological quality, terminal sterilization, and reprocessing, to include such activities as participating in the development of new products.
  
  

Plan

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

Source

• Provide microbiological quality and sterility assurance support for due diligence of sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into Johnson & Johnson.
• Provide microbiological quality and sterility assurance for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are contract manufactured.
• Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing perspective.
• Provide input for the design of critical water, air systems, controlled environments and cleanliness strategies.
• Provide microbiological quality and sterility assurance support for supplier audits.
  
  

Make

• Provide microbiological and sterility assurance support for strategic MAKE initiatives.
• Provide input into process risk assessments related to product cleanliness and sterility assurance.
• Lead, own and provide Subject Matter Expert (SME) input to corrective and preventative action (CAPA), non-conformance, audit observations and risk assessments.
• 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.
  
  

External Influencing

• Collaborate with external industry and provide input to standards associations (e.g. AAMI, ISO), influencing regulations and standards.
  
  

Internal Influencing

• Chair, lead and participate in MQSA Councils.
  
  

The Senior Scientist, MQSA technical support includes: aseptic processing, cleaning and disinfection requirements, sterilization validation (ethylene oxide, radiation, moist heat, and dry heat processes), device processing, 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. Author and review health authority submissions and health or safety risk assessments.

Qualifications

• A minimum of a Bachelor’s degree in a Science, Engineering or related discipline is required.
• A minimum of 4 years of experience in a Good Manufacturing Practice (GMP) and/or International Organization for Standardization (ISO) environment within the Medical Device and/or Pharmaceutical (combination) industry is required.
• Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a Medical Device or Pharmaceutical manufacturing facility is required.
• Experience with terminal sterilization, device processing, and microbiological quality is required
• Experience with multiple healthcare (clinical) and industrial (manufacturing) terminal sterilization methods (e.g. ethylene oxide, radiation, moist heat, dry heat) is required.
• Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred.
• Knowledge of regulations, standards and guidance, including European Medical Device Regulation (EU MDR), GMP and ISO, is required
• Experience interacting with regulatory agencies and notified bodies (e.g. FDA, EU, etc.) is preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
• People leadership (coaching, mentoring, influencing) experience is preferred.
• Must have excellent oral and written communication skills.
• Must have strong organizational and time management skills.
• Must have the ability to work independently and in a team environment.
• The ability to monitor and troubleshoot process non-conformances, out-of-specification test results, and providing resolution to issues by robust investigations and root cause analysis is required.
• The ability to collaborate with all levels (leaders, peers, business partners) in a matrix environment is required.
  
  

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.

Primary Location

United States-Massachusetts-Raynham-325 Paramount Drive

Other Locations

North America-United States-Indiana-Warsaw, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil

Organization

Medical Device Business Services, Inc (6029)

Job Function

R&D

Requisition ID

2105971639W