Engineering jobs

Browse our selection of 283 Engineering jobs below or use advanced job search to refine or expand the results.

  • FRS RECRUITMENT
    CSV ENGINEER PHARMA CORK
    FRS RECRUITMENT
    CORK
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  • CAREERWISE RECRUITMENT
    PROCESS MECHANICAL ENGINEER
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  • LOTUSWORKS
    JUNIOR INSTRUMENTATION ENGINEER
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  • CAREERWISE RECRUITMENT
    CONTROLS ENGINEER (NIGHT SHIFT)
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  • ICDS RECRUITMENT
    BUILDING SERVICES (M&E) COORDINATOR
    ICDS RECRUITMENT
    DUBLIN
  • CAREERWISE RECRUITMENT
    PROJECT MANAGER
    CAREERWISE RECRUITMENT
    LIMERICK
  • FRS RECRUITMENT
    TECHNICAL PRODUCT MANAGER
    FRS RECRUITMENT
    LONGFORD
  • CAREERWISE RECRUITMENT
    ASSISTANT ENGINEERING MANAGER
    CAREERWISE RECRUITMENT
    MAYO
  • SIGMAR RECRUITMENT
    SENIOR QUALITY ENGINEER
    SIGMAR RECRUITMENT
    GALWAY
CSV ENGINEER PHARMA CORK
Posted on:
22/10/2019
Location:
CORK
Salary:
NEGOTIABLE
Job type:
PERMANENT
Job reference number:
15473700
Client ID:
FRS34965
CSV Engineer, Cork

My client is a market leader in manufacturing solutions within the Biopharma & Pharmaceutical industries and they are looking for dedicated, innovative and driven talent to join their expanding teams.

A little about the role
  • As the Computer Systems Validation Engineer, you will work on large projects for one of Ireland's most prominent Pharma manufacturing sites. You, undoubtedly, will be familiar with this client and their fantastic company reputation.
  • You will be responsible for the Computer System Validation of IT solutions being implemented and will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.
  • The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
  • Experience of working in a pharmaceutical API manufacturing operation or a regulated environment required
  • Monday-Friday, days role. This role will start ASAP (ideally)

  • Permanent position with excellent benefits package and career progression opportunities!

    Responsibilities:


  • Manage the Computer System Validation aspect of IT projects from software install to business release
  • Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
  • Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions
  • Generate computer system validation documentation in accordance with site procedures and GMP guidelines
  • Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
  • Work with the business to identify and implement procedural controls to mitigate issues found during testing
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices
  • Determine solutions or recommendations for changes and/or improvements
  • Prioritize validation activities in line with the project schedule
  • Collaborating with global IT and Quality teams


  • You will have the following


  • Relevant Bachelors degree
  • 5 years relevant experience in a CSV role, working on projects within GMP Biopharma/Pharmaceutical Industry an absolute requirement
  • Minimum 5 years experience implementing IT solutions, systems integration, support & validating IT applications and interfaces
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
  • Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
  • Experience of OSI PI is an advantage
  • Experience of data analytics and reporting solutions is an advantage
  • Experience of server and workstation platforms and working in a Win 10 environment
  • Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
  • Self-motivated, detail-oriented and excellent organizational and time management skills

  • APPLY TODAY!

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    Contact Dara Bradley or email your CVmore information and/or to review the full job spec. I would be delighted to guide you through the whole process…


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