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Senior IT Engineer 2

1 month ago

Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time
About This Role

The Senior IT Engineer 2, CSV is a Subject Matter Expert (SME) responsible for leading tasks associated with Computer System Validation (CSV). This role provides input and determines action items on all GxP Manufacturing and IT Computerized Systems, prepares validation documentation, and maintains a validated state with a focus on consistent policy administration.

Key Responsibilities
  • Ensure CSV is conducted in a consistently high standard, within budget, and that objectives are met on time for the company's objectives
  • Provide plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM), and IT Computerized Systems
  • Lead and initiate the development of documents, processes, and procedures of the CSV program
  • Generate, review, and approve Manufacturing and IT Computerized Systems lifecycle documentation
  • Maintain the validation status of Manufacturing and IT Computerized Systems
  • Manage the allocation of contract CSV resources and monitor the quality of their deliverables to support local IT projects
  • Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices
  • Coordinate with Computer System vendors, as needed
  • Assess the impact of Computer System modifications and maintain change control
  • Lead CSV team to produce high-quality deliverables aligning to FDB's IT Quality Management Systems (QMS)
  • Identify and drive process improvement and implementation ideas to improve efficiencies
Requirements
  • Bachelor's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 8 years of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations
  • Experience in Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM)
  • Prior experience leading projects and/or teams
  • Effective communication, both written and verbal
  • Collaborative attitude working with global peers and cross-functional teams toward company and department goals
  • Ability to prioritize and work autonomously based on common goals and objectives
  • Strong analytical detail and problem-solving
  • Ability to lead through assignment of work tasks, development of project schedules, and management of timelines
  • Knowledge of Kneat validation software, IT Systems, including basic software and hardware principles, implementation options (on prem, cloud, etc.) and validation methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
  • Ability to travel domestic and international, up to 10%
Preferred Requirements
  • Master's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 6 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
  • Prior experience working in a CDMO environment