Validation Operations Manager

2 weeks ago


Durham, North Carolina, United States FUJIFILM Corporation Full time

Job Summary

FUJIFILM Diosynth Biotechnologies is seeking a Quality Assurance Operations Engineer to drive quality oversight for all Drug Substance Manufacturing processes through to operational readiness during project phase.


About the Company

We are a Contract Development & Manufacturing Organization (CDMO) that partners with clients to deliver recombinant proteins, viral vaccines, and gene therapies to patients.


Key Responsibilities

  • Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with Manufacturing Systems.
  • Develop and maintain documentation related to system and process lifecycle, including risk and impact assessments, product, process, and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
  • Ensure project and operational quality objectives are met within desired timelines.


Requirements

To be successful in this role, you will need:

  • Bachelor's degree in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience OR Master's degree in Life Sciences or Engineering and 4+ years of applicable experience OR PhD in Life Sciences or Engineering with no experience.
  • 3+ years of experience in GMP Quality Assurance and/or similar role.
  • Multiple years of experience, with increasing levels of responsibility and accountability, in Validation, cGMP manufacturing operations, and/or Quality oversight in an FDA regulated facility.
  • High level of familiarity/understanding of validation of production equipment, clean utilities, quality systems, automation, cleaning validation, manufacturing or IT systems.
  • Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.


Compensation

The estimated salary for this position is $135,000 per year, depending on experience.



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