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Process Engineer

  1. East
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
15-09-2023
32027
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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.

The candidate must have the rights to work in the location stated in the job advert.

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