CQV Engineer

Posted 31 January 2023
Salary€55 - €70 per hour
LocationDundalk
Job type Contract
DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
ReferenceBBBH29643_1675191044
ContactPadraig O Luasa

Job description

A leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for an experienced CQV Engineer with experience in the commissioning, qualification and validation of Aseptic Filling Line equipment. This site will manufacture for global supply and is expanding as a response to growing customer requirements. As this is the company's first site of this nature the engineering department will work closely with the global group to complete detailed doc design across processes and protocols as required. Previously the business would have worked through a network of CMO's to support customer projects, however, they have made the strategic decision to invest in their own operations here in Ireland.

The Position

As a key member of the site CQV project team you will be involved in leading and supporting all aspects of commissioning and validation for the site Aseptic Filling Line system. This is a challenging position and will require flexibility and creative approaches to problem solving.

  • Working on a team of experienced professionals; engineers and senior specialists across the site. You will work closely within this group and liaise with on-site teams to support the operational readiness plan from a CQV perspective.
  • Drive the review of and standards in the vendor documentation packages as well as in the organisation's qualification documentation (protocols/reports etc.).
  • You will work closely within this group and liaise with multi-disciplinary teams on-site to deliver effectively against the business objectives.
  • Assist with investigations of equipment such as, Vial Washers, Depyrogenation Tunnels, Filling Line (Isolator), Stoppering Machine, Blast Freezer, Lyophilisation (Freeze Dryers) Equipment/Processes, and Capper Machines

The Person

  • A strong communicator with the ability to work well within a cross-functional team to achieve a common objective.
  • Collaborative approach to work and a positive attitude will be a good fit with this team dynamic.
  • Thorough knowledge of safety, GMP and environmental regulatory requirements around process equipment.
  • Demonstrated capability within an audit environment (specifically EHS and GMP).

To discover more about this opportunity, apply now or contact Pádraig Ó Luasa at HRM on +353 87 428 0873 for a confidential discussion.