Scientist/Engineer - Manufacturing Investigator

1 week ago

Akron, Ohio, United States MassGenics Full time
Job Title: Scientist/Engineer

Join our team as a Scientist/Engineer and contribute to the success of our CAR T operations. As a key member of our Quality Assurance team, you will be responsible for leading manufacturing and QC investigation reports, executing root cause analyses, and collaborating with cross-functional teams to identify and implement corrective and preventive actions.

Key Responsibilities:
  • Conduct thorough investigations of OOS, OOT, and environmental monitoring events, utilizing root cause analysis tools and techniques.
  • Lead cross-functional investigation teams and close reports in a timely manner, ensuring effective communication and collaboration with stakeholders.
  • Perform GEMBA walks with stakeholders to better understand process steps and evaluate root cause analysis.
  • Work with functional teams to propose effective CAPAs, develop CAPA plans, and assure CAPA effectiveness.
  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
  • May initiate change control documentation and identify functional area SMEs to perform impact assessments as part of the change management process.
  • Ensure all investigations are completed in a timely manner, notify stakeholders of any delays, and provide technical support for manufacturing investigations/CAPAs/change controls as needed.
  • Support deviation investigation defense during audits and site inspections for QC compliance-related inquiries.
  • Handle complex issues and solve problems with minimal guidance, providing training to new investigation team members and serving as an author or technical reviewer of departmental procedures as appropriate.
  • Support manufacturing and Quality Control testing of CAR T products as needed, employing lean manufacturing/Six Sigma principles to continuously improve products, processes, and systems.
Requirements:
  • Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences, or related engineering discipline (advanced degree preferred).
  • Minimum 3 years of relevant work experience, preferably in a health authority-regulated environment.
  • Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
  • An equivalent combination of education and experience may substitute.
About Innova Solutions:

Innova Solutions is a global leader in technology and business transformation solutions, employing approximately 50,000 professionals worldwide. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. Our company is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.

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