Senior IT Engineer 2, CSV
6 days ago
The Senior IT Engineer 2, CSV is a Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determines action items on all GxP Manufacturing and IT Computerized Systems, as well as prepares validation documentation and maintains a validated state with a focus on consistent policy administration.
Key Responsibilities- Ensures that CSV is conducted in a consistently high standard, within budget, and that objectives are met on time for the company's objectives.
- Provides plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM), and IT Computerized Systems.
- Leads and initiates the development of documents, processes, and procedures of the CSV program.
- Generates, reviews, and approves Manufacturing and IT Computerized Systems lifecycle documentation, including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Maintains the validation status of Manufacturing and IT Computerized Systems.
- Manages the allocation of contract CSV resources and monitors the quality of their deliverables to support local IT projects.
- Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices.
- Coordinates with Computer System vendors, as needed.
- Assesses the impact of Computer System modifications and maintains change control.
- Leads CSV team to produce high-quality deliverables aligning to FDB's IT Quality Management Systems (QMS).
- Identifies and drives process improvement and implementation ideas to improve efficiencies.
- 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%.
- Masters 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.
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