Senior Scientist, R&D Expert

3 weeks ago


Cary, Illinois, United States Comrise Full time
Job Title: Senior Staff Scientist, R&D

Location: Onsite

Duration: 18-Month Contract, Full-Time

Responsibilities:

  • Ensure sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities.
  • Oversee 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.
  • Interpret sampling and monitoring data, applying statistical and analysis techniques, to determine 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, including product and process issues, root causing, projects, initiatives, and other business-critical forums.
  • 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 with respect to vendor sterility topics.
  • Perform sterility release review, interpreting data and trends.
  • Perform validations and re-qualifications in line with relevant BS EN ISO standards.
  • Continually identify opportunities for stabilization of trends, statistical control of processes, and cost savings.
  • Subject matter expert to internal and external regulatory requirements, including European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements.
  • Support ensuring compliance of new products to sites' sterile and non-sterile standards.
  • Ensure successful integration of products into validated processes.
  • Ensure biocompatibility of components, materials, and consumables used in the manufacture of company's product.
  • Provide Technical Assessment for completion of Risk Assessment in the area of microbiology.
  • Demonstrate knowledge of business processes and products across multiple sites.
  • Mentor and train team and cross-functional groups as required.

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.


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