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Process Engineer

  1. East
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
07-02-2024
32027
Process Engineer - Carlow - 11-Month Contract

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Carlow.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 


Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Manage multiple projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow.
  • Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
  • Develop project scope, cost, and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers.
  • Collaborate closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.
  • Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk.

Requirements:
  • Green Belt preferable.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects.
  • Experience in leading through change would be an advantage.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment.

If you are interested initially, please apply now for immediate consideration and further information.
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