IT Systems Engineer

The IT Systems Engineer is responsible for supporting entire IT infrastructure. This role will contribute to ABLs current and future automation strategy to improve Laboratory and manufacturing performance (e.g. yield improvements etc.) and ensure automation systems remain in compliance with cGMP requirements. This position will also support projects related to new process deployment and IT capability enhancements.

• Support all preventive maintenance activities on ABLs Network instrumentations and controls equipment.
• Assist operations with day-to-day running and troubleshooting of automated manufacturing systems.
• Manage and maintain Hyper-V and VMware cluster
• Manage and maintain Microsoft Office 365 Azure SharePoint Exchange Defender for Endpoint and Intune.
• Work closely with systems owners to effectively implement new computerized systems system upgrades and system modifications.
• Provide systems and network support including security management such as patches firewall configurations and related activities.
• Document network configurations changes and technical procedures to support reference training and knowledge sharing.
• Manage backup and restoration processes for validated systems.
• Work closely with system owners to effectively implement new computerized systems system upgrades and system modifications.
• Identify and leverage resources to perform regular security monitoring to detect intrusions and vulnerabilities.
• Support subject matter experts (SME) during project planning and implementation.
• Ensure all cGMP automation equipment meets minimum documentation requirements in accordance with ISPE GAMP5 guidelines.
• Ensure documentation adheres to Good Documentation Practices (GDP)
• Complete all assigned tasks following cGMPs OSHA EPA CMMC and other Federal and State regulations.
• Support the development and maintenance of automation Standard Operating Procedures (SOPs) and system drawings.
• Support all GxP and Lab monitoring and control systems.
• Perform annual system reviews for all automation systems working knowledge of administering building control systems
• Provide system support during Compliance Events (CEs) and Corrective Action Preventive Actions (CAPA) investigations.
• Perform small to medium automation code updates in accordance with ABL Change Control procedures.
• Provide on-call emergency support as required (in the event SME assistance is needed)/
• Support analysis troubleshooting diagnostics and repair of equipment in a timely manner to minimize production downtime.
• Other duties as assigned

• Bachelors degree
• 3-5 years of relevant experience
• Solid understanding of networks electricity electrical circuits analog and digital input/output.
• Prior experience with cGMP GxP and computer system validation (CSV).
• Knowledge of Documentation Management System Laboratory Information Monitoring Systems (LIMS).
• Knowledge of server hardware and operating systems including Windows and Linux
• Knowledge of backup and storage operations
• Ability to multi-task prioritize and work in a fast-paced environment.
• Able to host audits for regulatory bodies concerning IT policies and procedures
• Able to work with minimal supervision
• ABL to create and maintain Standard Operating Procedures
• Able to extend training sessions to internal groups
• Available to travel on minimal basis for training purposes
• Familiarity with high and low voltage equipment operation maintenance and the safe test procedures as required
• A record of safe operation and working knowledge of safety standards for plant environments
• Strong communication
• Remains calm under pressure
• Takes initiative
• Works well with all types of people
• Possess managerial courage