Specialist, Technical Support

About the role

The purpose of this role is to provide dedicated IT/OT support, including problem identification and troubleshooting of infrastructure, in compliance with cGMP standards for various Research laboratory & Manufacturing Plant systems. The role also contributes to continuous improvement initiatives supporting the Biologics development and clinical manufacturing & supplies.

Responsibilities

• Provide problem discovery and analytical support for the Manufacturing facilities in Rahway (NJ) / West Point (PA) and serve as a first point of contact liaising with Network and GIO teams to triage incidents and requests.
• Implement incident management processes using ITIL best practice.
• Monitoring and governance for the backup and recovery of IT systems.
• Performance monitoring of IT systems.
• Develop data analytics solutions for Rahway both independently and in conjunction with site & global teams.
• Work collaboratively with all key stakeholders at the site to ensure alignment on strategy and service level expectations.
• Manage the release management approach to critical software or system deployment.
• Ensure Service level agreements are in place and vendor management processes are clearly defined and governed.
• Influence system deployment and design to ensure that systems support critical path activities with robust, scalable, flexible, sustainable and highly available solutions.
• Operate and maintain OT systems, tools, and applications.
• Support IT/OT services including asset inventory, configuration management.
• Conduct risk assessments, obtain permits, and manage technician allocation.
• Perform investigations, change requests, and ensure compliance with engineering documentation standards.

Requirements

• 5 years of engineering experience in Automation in Chemical or Pharmaceutical industry.
• Proven experience in resolving software /automation problems & maintain reliable operation of all building control / automation and related systems while complying and supporting the global standards.
• Skills in C&Q within the automation (CSV).
• Extended knowledge of GxP / HSE & Quality systems.
• Excellent communications skills essential.
• High School Diploma or min 3 years equivalent practical experience in automation control systems within regulated environment.
• Thorough knowledge of computer validation/SDLC principles and automation change control procedures (e.g., GAMP 5).
• Strong technical competency with knowledge of pharmaceutical industry processes & practices.
• Demonstrated understanding of network, cloud and virtual server technologies.
• Knowledge of integrated software applications, including SCADA, MES and LIMS systems, in support of business processes in a pharmaceutical manufacturing environment.
• Demonstrated project management skills.
• Enterprise mindset, entrepreneurial spirit, self-starter, self-guided, hands-on person.
• Record of working independently, asynchronously (across time zones) and with excellent communication skills that cross culture / geographic / organizational boundaries.

Qualifications

• Record of working in a team of multidisciplinary scientists, IT/OT personnel, Product teams & operating effectively in a matrixed environment with a customer centric attitude.

Skills

• Availability Management
• Change Controls
• Engineering Document Management
• Global Team Collaboration
• Incident Management
• Information Technology (IT) Infrastructure
• Information Technology (IT) Support
• Issue Management and Remediation (IMR) Process
• IT Operation
• IT Project Lifecycle
• Management System Development
• Performance Monitoring
• Plant Equipment
• Problem Management
• Quality Assurance (QA)
• Release Management
• Service Delivery
• SLA Management
• Software Configurations
• Software Development Life Cycle (SDLC)
• System Deployment
• Testing
• Vendor Management