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Technical Specialist - Commissioning Engineer

  1. Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
11-09-2023
31973
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Technical Specialist - Commissioning Engineer – Life Sciences – 11-months - Ireland

One of our global Pharmaceutical clients is looking for a Technical Specialist - Commissioning Engineer to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide.

The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.

Technical Specialist - Commissioning Engineer  Responsibilities:
  • Ensure the highest Quality, Compliance and Safety standards primarily with equipment qualification, commissioning and validation, project management but relating to all activities.
  • Work within a team to enable the team’s performance within the Technology Transfer group and Tech Ops.
  • Responsible for the qualification of new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management.
  • Development and execution of protocols to support equipment qualification.
  • Technical Review, ownership of and impact assessment of Global Change management records as required.
About you:
  • 5-10 years’ process engineering experience in biopharmaceutical/vaccines environment would be an advantage.
  • Prior experience with equipment commissioning, qualification, and validation.
  • Prior experience with Lyophilisers would be an advantage.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
  • Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).  
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles
  • Project management qualification such as, Project Management Professional is desirable
  • Prior equipment qualification experience required.
  • Managing complex project and aligning key stakeholders.
  • Evidence of Continuous Professional Development
Are you a good fit for the role of Technical Specialist - Commissioning Engineer? Get in touch with us today.



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