Production IT Manufacturing Systems Coordinator
Amneal Pharmaceuticals LLC (J0P) - Branchburg, NJ
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Description:The position of Production IT Manufacturing Systems Coordinator will provide technology support for the manufacturing floor so that the production targets are met on time. This role will work cross-functionally to collaborate on various needs for system implementation and maintenance of technology at the manufacturing shop floor level. The position will also provide support on the production floor as needed during the manufacturing process.Essential Functions:Provide support with all software/applications related to Track and Trace / Serialization within manufacturing shop floor. Partner with IT to troubleshoot any issues in any of the applications/ databases.Provide assistance with track and trace regulatory systems and shop floor support during corrective action activities to bring necessary compliance requirements.Provides support for system implementation of practices and procedures to improve standard operationsAssist with validating design specifications and shop floor application of existing or new product, tools, or equipment.Support communication and training of staff regarding the changes to the existing database system.Analyze requests for user support and respond with comprehensive solutions or redirect to appropriate IT support.Assists with logistics and coordination of enhancements to reporting and data warehouse systems.Additional Responsibilities:Learn fundamental operations of commonly used software, hardware, and other equipment.Adhere to all confidentiality rules and policies.Follow all company and department policies and rules.Ensure that all problems are logged, resolved/assigned for resolution, prioritized and tracked, and communicated appropriately.Assist with Production floor activities as required.Other duties as assigned.Education:Bachelors Degree (BA/BS) IT, Computer Science, Manufacturing Pharmaceuticals, Mechanical Engineering or related field - RequiredExperience:1 year or more in IT, Manufacturing or MechanicalSkills:Clearly and effectively communicate cross-functionally and within team, both in writing and verbally. - IntermediateAbility to work extended hours and on call, over the company provided phone. - AdvancedKnowledge of 21CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP) and other regulatory requirements - IntermediateHigh attention to detail and accuracy - AdvancedKnowledge of HTML, JAVA SCRIPT, JQuery, XML - IntermediateSpecialized Knowledge:cGMP, SOP, Pharmaceutical, Production and Packaging processFamiliarity with systems like electronic logbooks, batch record management, and inventory management systems tailored to manufacturing processes.Understanding of Good Practices compliance in regulated industries such as pharmaceuticals, ensuring all activities adhere to legal standards.Knowledge of serialization technologies and systems for track and trace compliance, crucial for pharmaceutical packaging and distribution.Good knowledge and experience in Manufacturing Execution Systems (MES), preferably Factoryworks or Camstar softwareStrong understanding of both hardware and software systemsMechanical systems background preferredAbility to multi-task and prioritize both daily issues and longer-term projectsEqual Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
Created: 2024-09-23