Staff Scientist, Mqsa

Medical Device Business Services, Inc. is recruiting for a Staff Scientist, located in Raynham, MA or Bridgewater, MA!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Reporting to the Senior MQSA Manager, the Staff Scientist, MQSA 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. The Staff Scientist, MQSA will directly support product manufacturing at the Depuy Synthes manufacturing facilities in Raynham, MA and Bridgewater, MA.

The Staff Scientist, MQSA technical areas led all aspects of include: 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, compliance to applicable laws and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.

Key Responsibilities:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provide technical support in the selection, investigation and validation of aseptic manufacturing and sterilization methodologies

• Support due diligence on contamination control and sterility assurance for acquisitions and new product licensing

• Provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally

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

• Provide support in Business Unit/Franchise due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J

• Provide technical SME support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured

• Provide feedback in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint

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

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

• Ensure the implementation of contamination control and sterility assurance policies at defined manufacturing facilities

• Ensure process changes meet contamination control and sterility assurance requirements

• Lead the investigation, gap analysis and develop the corrective action plan for microbiological or contamination control CAPAs and non-conformances, including root cause identification and corrective action implantation within agreed timelines

• Supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.

• Provide technical support during onsite inspections

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

• Work with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization processes

• 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

• Monitors standard processes in sterility assurance and contamination control by interacting with JJSA leadership.

• Internal Influencing -

• Interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to use resources and ensure standard methodologies across facilities.

• Participate on the J&J Sterility Assurance Councils as assigned by management.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.