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Senior Staff Scientist, R&D

2 months ago

Cary, United States Comrise Full time

Job Title: Senior Staff Scientist, R&D

Location: Cary, IL (Onsite)

Duration: 18-Month Contract, Full-Time


Responsibilities:

  • In this role, you will be primarily responsible for microbial compliance of comany's product in accordance with relevant regulatory requirements and standards for medical devices
  • You will oversee and ensure sustained levels of compliance through testing, monitoring and validation of cleaning and sterilization processes and associated utilities
  • People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues
  • Establish or edit technical documentation as needed


Collaborative Partnership:

  • People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices
  • Working within the microbiology team, you will ensure effective and efficient sterility practices, which includes, but not limited to the following:
  • Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and endotoxin testing
  • Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending
  • Leads NC and CAPA generation and resolution within the Microbiology group and across related business units
  • Act as technical lead for microbiology in cross functional groups including product and process issues, root causing, projects, initiatives and other business critical forums
  • Applying cGLP to all laboratory activities including stock control
  • Performing sampling for validations and re-qualifications as required
  • Review of validation files for compliance
  • Interact with Supplier quality team with respect to vendor sterility topics
  • Performs sterility release review, interpreting data and trends
  • Performs validations and re-qualifications in line with relevant BS EN ISO standards
  • Continually identifies opportunity for stabilization of trends, statistical control of processes allow cost saving
  • Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements) Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements
  • Support of, ensuring compliance of new products to sites' sterile and non-sterile standards
  • Ensure successful integration of products into validated processes
  • Ensures biocompatible of components, materials and consumables used in the manufacture of company's product
  • Provides Technical Assessment for completion of Risk Assessment in the area of microbiology
  • Demonstrates knowledge of the business processes and products across multiples sites
  • Mentors and trains team and cross functional groups as required
  • Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role .


Qualifications:

  • Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations
  • Required Bachelor's degree in Microbiology or a related discipline 6 years' experience as a Microbiologist (Cleaning, Disinfection, Biocompatibility, or Sterilization) in a regulated industry
  • Strong competency in troubleshooting, correction of NC and root cause analysis