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Amneal Pharmaceuticals LLC (J0P)

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Senior Manufacturing Shopfloor IT Specialist (Biotech)



Description:

The Senior Manufacturing Shopfloor IT Specialist is responsible for the evaluation, selection, and implementation of critical OT (Operations Technology) systems, including SCADA, MES, and electronic Batch Record Management(eBRM), while also supporting the already implemented systems such as Track and Trace, JDEdwards (ERP), and rfSmart (WMS). The specialist will ensure seamless operations by troubleshooting and resolving system issues. Collaborate with business partners to define requirements and lead projects through to successful implementation. This role requires expertise in various OT and IT systems, as well as experience with system validation in manufacturing environments.

Essential Functions:

  • Digital Factory Roadmap: Contribute to the development of a long-term smart factory strategy, ensuring alignment with the company's digital transformation goals, operational efficiency targets, and business growth objectives. Lead the evaluation of OT systems, including SCADA, MES, eLogbook, and eBRM, assessing vendors based on business needs. Research and evaluate system capabilities, ensuring alignment with industry standards and regulatory requirements. Collaborate with procurement and legal teams to finalize contracts with vendors.
  • Business Collaboration: Work closely with business stakeholders and manufacturing teams to gather requirements and ensure systems meet business and operational goals. Act as the main point of communication between IT, Operations, and external vendors.
  • System Implementation: Lead the full project lifecycle for SCADA, MES, and eBRM systems, from initial planning to implementation and delivery. Ensure integration with existing OT and IT systems, including JDE, rfSmart, and eLogbook (Leucine), ensuring data flow across the organization. Manage risks and ensure successful project delivery within scope, budget, and quality expectations.System Support & Maintenance: Provide ongoing support for systems such as JDE, rfSmart, eLogbook (Leucine), BlueMountain, and Track and Trace systems (ACG, Systech, rfxcel, Optel), troubleshooting issues and ensuring continuous operation. Support and maintain ValGenesis for e-VLMS, ensuring the system's effectiveness in managing lifecycle validation processes.
  • Compliance & Validation: Troubleshoot and resolve issues related to JDE, rfSmart, eLogbook, BlueMountain, and Track and Trace systems. Excellent communication and vendor management skills. Strong problem-solving and critical thinking abilities.

 

Education:

  • Bachelors Degree (BA/BS) Computer Science, Information Technology, or related discipline - Required

Experience:

  • 5 years or more in Professional experience focusing on business, process or systems analysis and requirements management

Skills:

  • Expertise in manufacturing processes and regulatory standards - Mastery
  • Strong project management skills, with the ability to manage stakeholders and deliver complex projects - Mastery
  • Excellent communication and vendor management skills. - Advanced
  • Strong problem-solving and critical thinking abilities. - Mastery

Specialized Knowledge:

  • Hands-on experience with SCADA, MES, eBRM, and Track and Trace systems
  • Knowledge of ERP system, preferably JDE, rfSmart, eLogbook
  • Track and Trace Systems and Serialization
  • Experience with ValGenesis for e-VLMS and HMI/PLC validation processes

The base salary for this position ranges from $105,000 to $125,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.

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