Hikma Pharmaceuticals USA Inc.

  • Computer Engineer III Validation

    Job Location US-OH-Columbus
    Posted Date 3 days ago(8/11/2018 7:45 AM)
    Job ID
    2018-4707
    Job Function
    Quality
  • Overview

    Provide project leadership and guidance on validation/qualification initiatives to internal project teams and external validation firms and ensure project schedules are met. Ensures that West-Ward Pharmaceuticals systems, both computer and equipment, are in compliance with regulatory requirements. Investigates and makes sound recommendations for validation compliance concerns or new regulations.

    Responsibilities

    • Serves as project manager for validation/qualification aspects of complex projects in targeted areas. Arranges for contract validation services when required. This includes contract review, coordination of approvals and interface with contract service personnel in the oversight of the validation activities to make certain resources are available to meet validation project deliverables inclusive of schedule and budget.
    • Ensures that the system’s validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system as well as an annual security audit. Executes validation role in validated system access process.
    • Author validation plans; Oversee and provide direction for the development of: specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, and performance of both software and equipment. Provide direction on Equipment/Computer Change Control development. Lead assessment of computerized systems Electronic Record and Electronic Signature capabilities.
    • Development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates including test cases.
    • Mentors and trains colleagues on policies and procedures including the requirements for validation.
    • Investigates and identifies industry trends in validation and expectations of regulatory agencies and modifies the program to current requirements.

    Qualifications

    • Bachelors degree in engineering or related scientific discipline required with a minimum of six (6) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting. Require 3-5 years specific software or equipment validation experience in a pharmaceutical environment. Three years experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience preferred.
    • Demonstrated experience in equipment qualification and software validation across multiple applications, systems and equipment types required. Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports.

    • Minimum 5 years experience in project management required with demonstrated ability to manage multiple simultaneous projects.

    • Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements and 21 Code of Federal Regulations (CFR) Part 11 requirements.

    • Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.

    • Experience working with validation and construction contractors to facilitate project deliverables.

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