• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Process Automation CSV – Co. Meath

    Role Summary


    • A vacancy has arisen for a Computer Automation CSV to join our client’s busy pharmaceutical facility in Co. Meath.
    • The successful candidate will generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of the company’s representatives responsible Process Automation Remediation Plan delivery.


    Core Duties and Responsibilities:


    • Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery.
    • Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
    • Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
    • Provide technical support for the development of electronic data review procedures
    • Actively manage the execution of all CSV testing with right first time approach.
    • Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained.


    Minimum Qualifications and Experience:


    • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
    • At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
    • A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
    • Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
    • Experience in PLC/SCADA/DCS systems


    To Apply: Quote – PE22069


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.