Senior Manufacturing ShopFloor IT Specialist (Biotech)

Description:

The Senior Manufacturing Shopfloor IT Specialist is responsible for the evaluation, selection, and implementation of critical Operations Technology (OT) systems, including SCADA, MES, and electronic Batch Record Management (eBRM) while also supporting existing systems such as Track and Trace, JD Edwards (ERP), and rfSmart (WMS). This role ensures seamless operations by troubleshooting and resolving system issues, collaborating with business partners to define requirements, and leading projects through successful implementation. The position requires expertise in OT and IT systems along with experience in system validation within manufacturing environments to drive efficiency and compliance.

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.

Key Responsibilities:

• System Management:
  Lead the administration and support of manufacturing IT systems, including MES, SCADA, LIMS, and other shop floor automation tools, ensuring their reliability and efficiency.
• Track and Trace:
  Manage and support Track & Trace systems for serialization and product traceability, ensuring compliance with DSCSA and other global regulatory requirements.

Technical Skills:

• Advanced troubleshooting skills for IT systems, networks, and databases.
• Knowledge of manufacturing automation technologies and IT security best practices.
• Familiarity with Track & Trace, serialization, and data integrity requirements.
• Experience with data analytics and reporting tools.

 

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

 

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.