Principle Scientist MQSA Full-time

Principal Scientist, Microbiological Quality & Sterility Assurance

The Principal Scientist, Microbiological Quality & Sterility Assurance (MQSA) position is responsible for the end-to-end execution of microbiological quality, sterility assurance policies and strategies for Johnson & Johnson Vision franchise which are aligned with the overall Johnson & Johnson microbiological sterility assurance strategic priorities.

He/she will serve as the global technical leader in the areas of New Product Introduction, Method/Product Validations/Transfers, Regulatory Affairs Support, aseptic processing, sterilization, and microbiological quality with responsibility for all Johnson & Johnson Vision locations worldwide. This individual will be responsible for deployment of the company policy and company strategies with respect to cleanliness, aseptic processing, sterilization, clean rooms, water systems and microbiological quality related areas.

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

R&D –

• Core team member as required for NPI, selection of modalities, business case development, screening/feasibility cycle support, protocol and report writing, liaise with Regulatory Affairs on potential requirements for submission.
• Drive new contract sterilization site validation – on site visits, cycle development, process characterization, process validations, protocol and reports, regulatory affairs support for submissions, and questions from regulatory bodies.
• Support the development of new innovations in the area of contamination control and terminal sterilization, to include such activities as interaction with universities, internal and external experts, participating in development of new products.
• Work directly with the Technical Vertical MQSA Leaders to find break-through technologies to enable future growth and innovations.
• Work directly with the packaging leaders to define package needs for terminal sterilization and/or aseptic processing, and validation of the primary packaging, review and approval of protocols and reports as SMEs.
• Work directly with the biocompatibility and chemistry to support the impact of sterilization on Biocomp and chemistry requirements for terminal sterilization and/or aseptic processing, and validation of the NPI, review and approval of protocols and reports as SMEs.
• Life cycle management of aseptic processing, microbiological and/or sterilization process for product portfolio within Johnson & Johnson Vision.
• Support and drive the Technology Strategy for 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.
• Where applicable, own and drive test method development, validations and transfer including review and approval of protocols and reports as SMEs.

Plan –

• 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 manufacturers, critical suppliers and third-party manufacturers).
• Review and SME input of quality agreements for sterilization contracts, EMs, contract labs etc.
• Site visits as required and requested, audit support and follow up post audit to drive compliance.

Source –

• Mandatory involvement in due diligence for 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 or microbiologically controlled products that are externally manufactured.
• Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological and terminal sterilization standpoint.
• Input for the design of water systems and the design of controlled environments and cleanliness control strategies.
• Support change control and process improvements, cost avoidance projects, BCP, increased capacity.
• Mandatory involvement in sterilization, microbiology, cleanroom and utilities procedure updates.
• 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.
• Investigation support for sterilization/microbiology/utilities/cleanroom, sterility issues.
• Regulatory Affairs support for site changes/notifications.
• Improve on-site core competencies for sterilization/microbiology/utilities/cleanroom, sterility issues.
• Regulatory and internal audit readiness program support for on site audits, including site walkabouts.
• Support on site external and internal regulatory audit visits, presentation to site auditors support and follow up post audit to drive compliance.
• Support for onsite GEMBA walks of cleanrooms and manufacturing areas.
• Support for Sterilization/Environmental/Utility annual revalidation activities – requirement definitions, protocols and reports.
• Support for escalations, RMB, QRB.
• 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.
• Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
• Represent the corporation at industry and standards associations (e.g., AAMI, ISO, or PDA), influencing regulations and standards.
• Actively participate in the MQSA councils, AAMI working groups, support regulatory/Microbiological/Sterilization conferences, MQSA community meetings, town halls.
• Work with universities to develop a relationship that allows for the opportunity to develop next generation of J&J employees from a microbiological quality and sterility assurance viewpoint.

Internal Influencing –

• Represent MQSA on the Design to Value/Manufacturability Teams.
• Execute programs to develop/train/maintain MQSA competencies across the organization for new hires, as well as current/next generation sterility assurance professionals.
• Activity engage and shape MQSA councils and community of practices.
• Support for defining the contamination control strategy and support for ongoing compliance and sustainability.

The Principal 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.

Job Qualifications:

Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device manufacturing facility. Demonstrated competency in terminal sterilization and microbiological quality is required. Demonstrated competency in multiple industrial terminal sterilization methods (e.g., Gas and heat (moist heat, dry heat, VHP, EO), aseptic processing, radiation (gamma, electron beam, x ray), reprocessing) is required. Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity is required. Experience in interacting with Regulatory Authorities is preferred. Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred. Proven track record on trouble shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results, and providing resolution to issues via robust CAPA is required. High level knowledge of global external standards is required. Capable of representing the corporation at industry and standards associations is desired. Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required. Demonstrated ability to work in a collaborative/teamwork environment is required. Independent organizational and time management skills is required. Team player with a customer focus is required.

Required Education and Experience:

An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree, MS or PhD,