Senior Staff Scientist, R&D

---

Job description

Title - Senior Staff Scientist

Months- 18 + Months (potential extension)

Location : Cary IL

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
Responsibilities
In this role, you will be primarily responsible for microbial compliance of '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 to 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 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

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

<!– job description page –>