Specialist, Technical Support

Job Description

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.

• Provide problem discovery and analytical support for the Manufacturing facilities in Rahway (NJ) / West Point (PA) and serve as the first point of contact liaising with Network and GIO teams to triage incidents and requests.
• Implement incident management processes using ITIL best practice.
• Perform monitoring and governance for the backup and recovery of IT systems.
• Perform performance monitoring of IT systems.
• Develop data analytics solutions for Rahway 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, leveraging best practices.

• 5 years of engineering experience in Automation in Chemical or Pharmaceutical industry.
• Proven experience in resolving software/automation problems & maintaining reliable operation of all building control/automation and related systems while complying with global standards.
• Skills in CSV within the automation (C&Q).
• Extended knowledge of GxP / HSE & Quality systems.
• Excellent communication skills.
• High School Diploma or minimum 3 years equivalent practical experience in automation control systems within a 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.

• 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.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.