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CQV Lead

  • Job reference: 935908
  • Location: Meath
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Building, Construction & Infrastructure
  • Date posted: 08/06/2021

Orion Group Life Sciences have an exciting opportunity for a COV Lead /Senior CQV Engineer for our Multinational Biopharmaceutical client based in the Co. Meath/North Dublin area on an initial 11-month contract.

Job Purpose
The initial capital project to build the plant is nearing completion and the site is in the process of standing up a sustaining CQV program. The role shall be a combination of hands-on execution in the field while supporting the CQV lead in standing up the sustaining CQV program.

Responsibilities

  • Work with the sustaining teams involved in change controls to develop and execute test protocols.
  • Work with the CQV Lead to support the close out of the initial Validation Master Plan used to build the site.
  • Support the development of Validation Templates for a new capital project to bring new products to site.
  • Support the planning of the site activities for a new capital project to bring new products to site.
  • Support the development of Standard Operating Procedures for the sustaining CQV program.
  • Support the development of training materials to help build CQV capabilities across the site.
  • Co-ordinate the day-to-day management of contractors when qualification activities are outsourced e.g., Temperature Mapping, HVAC requalification, Autocalve requalification etc.


Desired Experience and Background of the successful candidate

  • Level 8 degree in a Sciences, Engineering or Other related technical discipline
  • Experience developing validation documentation.
  • Experience executing validation protocols.
  • Experience closing out validation activities and writing validation reports.
  • Project management experience a plus
  • Ability to analyse data and make recommendations.
  • Experience in working with cross functional teams.
  • Excellent report, standards, technical writing skills
  • Proficiency in Microsoft Office suite and job-related computer applications required.

    For more information on this role, call Dan on +353 868140295 or email Daniel.ryan@orioneng.com for a completely confidential chat.

For more information on this role, call Dan on +353 868140295 or email Daniel.ryan@orioneng.com for a completely confidential chat.


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.