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Senior Validation Engineer

  • Job reference: 926883
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 01/08/2019

Orion Group are looking for a Senior Validation Engineer for our multinational medical devices client based in the Limerick area on an initial 6-month contract with the potential to extend.

Job Purpose
Support the activities of Operations/Engineering/Information Management in assuring compliance with the pertinent regulations. Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions. Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.

Main Responsibilities of the role

  • Responsible for supporting the activities of Operations/Engineering/Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
  • Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
  • Runs/Manages complaint investigation and resolution of same
  • Designs and develops validation documentation to support business continuity, new process introductions
  • Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
  • All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform
  • Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within

Desired Experience and Background of the successful candidate

  • A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
  • Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities
  • Knowledge of bespoke validation. Process knowledge and documentation
  • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
  • Working experience of validation computer systems for use in a FDA regulated environment
  • Be very familiar with the relevant regulatory standards (F.D.A.-Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets
  • Have good knowledge of statistical techniques in the use of problem solving/ data analysis
  • Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
  • Must be able to lead and give direction to Validation Projects and Teams.
    Individual must also be an active team member in Validation activities
  • Must be able to lead and give direction to Validation Projects and Teams
    Individual must also be an active team member in Validation activities
  • Facilitates, encourage and coordinate continuous improvement with respect to validation activities
  • Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
  • Must be able to lead and give direction to Validation Projects and Teams
  • Individual must also be an active team member in Validation activities
  • Good Influencing Skills
  • Project Management Skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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