Dexian DISYS
Senior Staff Scientist, R&D
Dexian DISYS, Cary, Illinois, United States, 60013
Senior Staff Scientist, R&D
Job detailsPosted:
18 September 2024Location:
Cary, ILJob type:
PermanentReference:
936317Job descriptionTitle:
Senior Staff ScientistMonths:
18 + Months (potential extension)Location:
Cary ILQualifications:Relentless about quality, thriving in a fast-paced environment to ensure project completion meets regulations and expectations.Required Bachelor's degree in Microbiology or a related discipline with 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:Responsible for microbial compliance of products in accordance with relevant regulatory requirements and standards for medical devices.Oversee and ensure sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities.Identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.Establish or edit technical documentation as needed.Build and leverage cross-functional relationships to develop best practices.Ensure effective and efficient sterility practices, including oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards.Interpret sampling and monitoring data, applying statistical and analysis techniques for control and trending.Lead 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.Apply cGLP to all laboratory activities including stock control.Perform sampling for validations and re-qualifications as required.Review validation files for compliance.Interact with Supplier quality team regarding vendor sterility topics.Perform sterility release review, interpreting data and trends.Perform validations and re-qualifications in line with relevant BS EN ISO standards.Identify opportunities for stabilization of trends and statistical control of processes.Serve as subject matter expert to internal & external regulatory requirements.Support compliance of new products to site's sterile and non-sterile standards.Ensure successful integration of products into validated processes.Ensure biocompatibility of components, materials, and consumables used in manufacturing.Provide Technical Assessment for completion of Risk Assessment in microbiology.Demonstrate knowledge of business processes and products across multiple sites.Mentor and train team and cross-functional groups as required.Employees and new hires in sales and field roles may be required to obtain various vaccinations based on customer requirements.About Dexian: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. Visit
https://dexian.com/
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.
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Job detailsPosted:
18 September 2024Location:
Cary, ILJob type:
PermanentReference:
936317Job descriptionTitle:
Senior Staff ScientistMonths:
18 + Months (potential extension)Location:
Cary ILQualifications:Relentless about quality, thriving in a fast-paced environment to ensure project completion meets regulations and expectations.Required Bachelor's degree in Microbiology or a related discipline with 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:Responsible for microbial compliance of products in accordance with relevant regulatory requirements and standards for medical devices.Oversee and ensure sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities.Identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.Establish or edit technical documentation as needed.Build and leverage cross-functional relationships to develop best practices.Ensure effective and efficient sterility practices, including oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards.Interpret sampling and monitoring data, applying statistical and analysis techniques for control and trending.Lead 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.Apply cGLP to all laboratory activities including stock control.Perform sampling for validations and re-qualifications as required.Review validation files for compliance.Interact with Supplier quality team regarding vendor sterility topics.Perform sterility release review, interpreting data and trends.Perform validations and re-qualifications in line with relevant BS EN ISO standards.Identify opportunities for stabilization of trends and statistical control of processes.Serve as subject matter expert to internal & external regulatory requirements.Support compliance of new products to site's sterile and non-sterile standards.Ensure successful integration of products into validated processes.Ensure biocompatibility of components, materials, and consumables used in manufacturing.Provide Technical Assessment for completion of Risk Assessment in microbiology.Demonstrate knowledge of business processes and products across multiple sites.Mentor and train team and cross-functional groups as required.Employees and new hires in sales and field roles may be required to obtain various vaccinations based on customer requirements.About Dexian: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. Visit
https://dexian.com/
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.
#J-18808-Ljbffr