Staff Scientist, Microbiological Quality & Sterility Assurance

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The Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA) at Johnson & Johnson Vision is responsible for the end-to-end execution of microbiological quality and sterility assurance strategies and policies. These responsibilities will align with the strategic priorities of Johnson & Johnson’s microbiological sterility assurance initiatives.

In this role, the Staff Scientist will support the global technical leader in areas including New Product Introductions (NPI), Method/Product Validations/Transfers, Regulatory Affairs Support, aseptic processing, sterilization, and microbiological quality across all Johnson & Johnson Vision locations worldwide. This individual will oversee the implementation of company policies concerning cleanliness, aseptic processing, sterilization, clean rooms, water systems, and microbiological quality.

R&D:

o    Serve as a core team member for NPI, collaborating on modality selection, business case formulation, and protocol/report writing while liaising with Regulatory Affairs for submission requirements.

o    Lead on-site validation for new contract sterilization sites, which includes conducting visits, cycle development, process characterization, validations, and providing regulatory support.

o    Collaborate on innovative contamination control and terminal sterilization solutions, engaging with academic and industry experts.

o    Work closely with Technical Vertical MQSA Leaders to explore groundbreaking technologies that support future growth.

o    Support defining packaging requirements for terminal sterilization/aseptic processing, participating in review and approval of relevant protocols and reports.

o    Partner with biocompatibility and chemistry teams to evaluate the impacts of sterilization on product requirements.

o    Life cycle management of aseptic processing, microbiological and/or sterilization process for product portfolio within Johnson & Johnson Vision.

• Partner with R&D and drive sterility assurance strategy for new product development to include the BCP and environmental footprint for sterilization and contamination control undefined.
• Where applicable, own and drive test method development, validations and transfer including review and approval of protocols and reports as SMEs.

Plan:

• Provide support for the selection of new manufacturing operations (to include aseptic processing manufacturing sites, contamination control strategy, review of site competencies, contract sterilization, contract laboratories, external manufactures, critical suppliers and third-party manufacturers).

• Review and provide expert input into quality agreements for sterilisation contracts, EMs, contract labs etc.

o    Conduct site audits as needed to ensure compliance and support corrective actions post-audit.

Source:

o    Participate in due diligence for sterile or microbiologically controlled products, offering technical expertise for integration into Johnson & Johnson.

o    Provide technical SME support for procurement activities that relate to sterile or microbiologically controlled products that are externally manufactured.

o    Assist in the design of new manufacturing processes, controlled environments, and cleanliness control strategies.

• Support change control and process improvements, cost avoidance projects, BCP, increased capacity.

o    Support updates and improvements for relevant procedures in sterilization, microbiology, and cleanroom management.

• Microbiological/chemical, new equipment and test method validations – input, protocol/report review and approval.

• Standard gap assessments completion and support for gap closure.

• Kaizen support, core team members for site issues, escalations, RMB, QRB related to sterility.

• Investigation support for sterilisation/microbiology/utilities/cleanroom, sterility issues.

• Regulatory Affairs support for site changes/notifications.

• Support Regulatory and internal audit readiness programs in preparation for on site audits, including site walkabouts.

• Support on site external and internal regulatory audit visits, presentation to site auditors and support corrective actions post-audit.

• Support for onsite GEMBA walks of cleanrooms and manufacturing areas.

• Support for Sterilisation/Environmental/Utility annual revalidation activities – requirement definitions, protocols and reports.

• Maintain an active presence at manufacturing sites to align with Quality and R&D, assessing sterility risks, and identifying areas for remediation.

o    Provide on-site support for ongoing training and improvement of technical capabilities related to microbiological quality and sterility assurance.

Make:

• Maintain close involvement/alignment with the R&D organization to develop technical competencies for future products

• Maintain close involvement/alignment with the Make Organization manufacturing sites, with a pro-active scan from a sterility risks standpoint and drive remediation if required, and to establish long-range microbiological quality & sterility assurance strategies for Johnson & Johnson Vision products.

Deliver:

• Support the ongoing initiatives regards the validation and improvement of primary sterile products/finished goods (end to end process) that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer undefined.

External Influencing:

o    Network with scientific, technical, and regulatory communities to stay at the forefront of industry knowledge.

o    Represent Johnson & Johnson at industry standards associations (e.g., AAMI, ISO), actively participating in MQSA councils and working groups.

Internal Influencing:

o    Represent MQSA in cross-functional teams focused on Design for Value and manufacturability improvements.

o    Implement training programs to cultivate MQSA competencies across the organization and engage in strategic contamination control efforts.

The Staff Scientist of Johnson & Johnson Vision, will own the technical areas including: Aseptic Processing validation, sterilization validation (e.g., EO, gamma, electron beam, moist heat, and dry heat processes), Microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, BET), Environmental control and monitoring, Water 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.

• Extensive experience in microbiology, sterilization validation (terminal, aseptic, reprocessing), and environmental control practices within medical device manufacturing.
• Proven expertise in multiple sterilization methodologies (e.g., Gas and heat processes, aseptic processing, radiation).
• Strong capability to lead and mentor a diverse, multinational practice community.
• Prior experience interacting with regulatory authorities and conducting technical assessments is preferred.
• Successful track record in troubleshooting issues related to microbiological and sterilization processes with effective CAPA implementation.
• High knowledge of global external standards and the ability to represent the company at industry associations.
• Excellent communication skills, with the ability to effectively engage with various stakeholders.
• Strong organizational and time management skills, coupled with a collaborative approach to teamwork.
• Team player with a customer focus is required.

• A minimum of a Bachelor’s degree in Microbiology, Biology, Engineering, or a related discipline; advanced degrees (MS or PhD) are preferred.
• At least 8 years of experience in the medical device or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Proficient in software tools including Excel, Word, PowerPoint, and analytical software applications.