• Controls System Validation Associate Engineer

    Job Locations IE-Galway
    Job Post Information* : Posted Date 5 months ago(9/27/2018 12:13 PM)
    # of Openings
  • Overview

    Reporting to the Snr Validations Engineer the Computer Systems Validation (AE) will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions.


    • Requires a Level 8 or higher degree in an engineering or science discipline with a minimum of 2-3 years of related experience (medical device/pharmaceutical preferred).
    • Experience in medical device/pharmaceutical industry in the development and deployment of quality systems, process controls and continuous improvement systems.
    • Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA
    • Knowledge and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control.
    • MS Office competency demonstrated.
    • Excellent interpersonal, verbal and written communication skills.
    • Adaptable and able to work in a fast paced, dynamic work environment.  
    • Able to management multiple projects with competing schedules.
    • Knowledge of software development methodologies.
    • Knowledge of ERP, database systems and architecture.
    • Knowledge of PLC programming methodologies and systems.


    • Coordinates and communicates all testing with affected functional groups and evaluates test results
    • Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards
    • Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
    • Develop and communicate requirements for quality performance, continuous improvement infrastructure for critical software installations.
    • Write validation plans, reports and procedures.
    • Execute manual tests for software and system validation. Carefully analyse and document test results.
    • Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests.
    • Ensure validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate.
    • Coordinate and participate in the development, testing and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software.
    • Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage.  


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