Hikma Pharmaceuticals USA Inc.

  • Engineer IV, Validation Services

    Job Location US-OH-Columbus
    Posted Date 2 weeks ago(11/27/2018 5:13 PM)
    Job ID
    2018-4921
    Job Function
    Engineering
    Shift
    Columbus First Shift
  • Overview

    Provides project leadership and guidance on large/complex 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. Assumes major role during agency inspections. Investigates and makes sound recommendations for validation compliance concerns or new regulations.

    Responsibilities

    • Serves as project manager for complex validation/qualification aspects of multi-faceted focus projects (> $1MM). Arrange 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.
    • 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.
    • 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.
    • Investigates and identifies industry trends in validation and expectations of regulatory agencies and modifies the program to current requirements.
    • Mentors and trains colleagues on policies and procedures including the requirements for validation.
    • Development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates.

    Qualifications

    • Bachelors degree in engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting. Require minimum 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.

    • Experience and Inspection interaction with FDA, EMA or other regulatory agencies required.
    • Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements and 21 Code of Federal Regulations (CFR) Part 11 requirements.
    • Experience working with validation and construction contractors to facilitate project deliverables.

     

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