Sr. IT Engineer 2, CSV

Fujifilm - Holly Springs, NC

Full-time - Mid Level

Holly Springs, NC

Machinery Manufacturing

About the position

The Senior IT Engineer 2, CSV is a pivotal role within Diosynth Biotechnologies, serving as the Subject Matter Expert (SME) for Computer System Validation (CSV). This position is critical in ensuring that all GxP Manufacturing and IT Computerized Systems are validated and maintained in compliance with regulatory standards. The engineer will be responsible for preparing validation documentation, maintaining a validated state, and ensuring consistent policy administration across the organization. This role requires collaboration with various workstreams and IT departments at different locations to align strategies and procedures effectively. The Senior IT Engineer will also facilitate improvement initiatives and support regulatory agency inspections as necessary. In this role, the engineer will ensure that CSV processes are conducted to a high standard, within budget, and that all objectives are met on time. Responsibilities include developing qualification plans for Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM), and IT Computerized Systems. The engineer will lead the creation of essential documents and processes for the CSV program, including risk assessments, user requirement specifications, functional specifications, and validation plans. Additionally, the engineer will manage the validation status of systems and oversee contract CSV resources, ensuring the quality of their deliverables. The Senior IT Engineer will also coordinate with Computer System vendors and assess the impact of any modifications to systems, maintaining strict change control. This role requires a proactive approach to identifying and implementing process improvements to enhance efficiency within the CSV framework. Other duties may be assigned as needed, contributing to the overall success of the IT Quality Management Systems (QMS) at Diosynth Biotechnologies.

Responsibilities

• Ensure that CSV is conducted to a high standard, within budget, and that objectives are met on time.
• Provide plans for the qualification of Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM), and IT Computerized Systems.
• Lead the development of documents, processes, and procedures for the CSV program.
• Generate, review, and approve lifecycle documentation for Manufacturing and IT Computerized Systems.
• Maintain the validation status of Manufacturing and IT Computerized Systems.
• Manage the allocation of contract CSV resources and monitor the quality of their deliverables.
• Collaborate with other 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 the CSV team to produce high-quality deliverables aligning with FDB's IT Quality Management Systems (QMS).
• Identify and drive process improvement initiatives.

Requirements

• Bachelor's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields.
• 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 skills, both written and verbal.
• Collaborative attitude working with global peers and cross-functional teams.
• Ability to prioritize and work autonomously based on common goals and objectives.
• Strong analytical detail and problem-solving skills.
• Ability to lead through assignment of work tasks, development of project schedules, and management of timelines.
• Knowledge of Kneat validation software and IT Systems, including validation methodologies.

Nice-to-haves

• Master's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields.
• 6 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations.
• Prior experience working in a CDMO environment.