Azzur Group
  • Raleigh, NC, USA
  • Hourly
  • Contract

Partial


Computer System Validation professionals develop, review and conduct activities related to the validation of Manufacturing Execution Systems (MES) and/or Enterprise Resource Planning (ERP) systems and processes to establish and ensure compliance. This involves all regulated systems through their life cycle including planning, requirements, specification, design, test, install and verification.

Essential Duties and Responsibilities

  • Review and evaluate MES/ERP system, as well as, related Automation/Process Controlsystems, strategies, policies, standards, processes, SOP's and other documents and provide guidance as needed.
  • Develop and perform all MES/ERP system activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Develop and complete deliverables as needed and in line with project/business objectives.

Qualifications

  • College degree or equivalent work experience; Ten plus years of MES/ERP system validation experience in a plant/production environment.
  • Effective organization, communication and interpersonal skills and the ability to manage priorities in a time sensitive environment.
  • Proficiency using computer software and systems related to performing system/equipment activities; experience with MES/ERP systems (e.g. SAP, Syncade) and Process Control Systems such as Delta V. 
  • Knowledge in GAMP, Instrumentation and related regulations and standards.
Azzur Group
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