IT Systems Engineer

ABL Home•Rockville, MD

About The Position

The IT Systems Engineer is responsible for supporting entire IT infrastructure. This role will contribute to ABL’s 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 ABL’s 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 (SOP’s) 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 (CE’s) 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

Requirements

Bachelor’s 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

Responsibilities

Supporting entire IT infrastructure
Contributing to ABL’s current and future automation strategy to improve Laboratory and manufacturing performance
Supporting projects related to new process deployment and IT capability enhancements
Supporting all preventive maintenance activities on ABL’s Network, instrumentations and controls equipment
Assisting operations with day-to-day running and troubleshooting of automated manufacturing systems
Managing and maintaining Hyper-V and VMware cluster
Managing and maintaining Microsoft Office 365, Azure, SharePoint, Exchange, Defender for Endpoint and Intune
Working closely with systems owners to effectively implement new computerized systems, system upgrades and system modifications
Providing systems and network support, including security management such as patches, firewall configurations, and related activities
Documenting network configurations, changes, and technical procedures to support reference, training, and knowledge sharing
Managing backup and restoration processes for validated systems
Identifying and leveraging resources to perform regular security monitoring to detect intrusions and vulnerabilities
Supporting subject matter experts (SME) during project planning and implementation
Ensuring all cGMP automation equipment meets minimum documentation requirements in accordance with ISPE GAMP5 guidelines
Ensuring documentation adheres to Good Documentation Practices (GDP)
Completing all assigned tasks following cGMPs, OSHA, EPA, CMMC and other Federal and State regulations
Supporting the development and maintenance of automation Standard Operating Procedures (SOP’s) and system drawings
Supporting all GxP and Lab monitoring and control systems
Performing annual system reviews for all automation systems, working knowledge of administering building control systems
Providing system support during Compliance Events (CE’s) and Corrective Action Preventive Actions (CAPA) investigations
Performing small to medium automation code updates in accordance with ABL Change Control procedures
Providing 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