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Jobs · Information Technology · North Carolina

Sr. Engineer 1, Commissioning Qualification and Validation

FUJIFILM Biotechnologies · Holly Springs, NC · 5 days ago
Information TechnologyFull-time

About the role

The Sr CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

Responsibilities

  • Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
  • Collaborates with cross-functional teams to deliver projects on time and in full completeness
  • Contributes to building and maintaining routine statistical process control methods and multivariate models for process trending and monitoring
  • Serves as on-call for process analytics issues and concerns
  • Serves as part of the role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (GMP) environment
  • Supports role in Good Manufacturing Practices (

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