Specialist, Technical Support

MSDRahway, NJ
Hybrid

About The Position

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.

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.
  • 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

Nice To Haves

  • 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

Responsibilities

  • Will provide problem discovery and analytical support for the Manufacturing facilities in Rahway (NJ) / West Point (PA) and will 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 solutions leveraging best practices

Benefits

  • medical
  • dental
  • vision healthcare
  • other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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