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Engineering & Technical

Job Description

PROCESS ENGINEER required by CareerWise Recruitment to to support a multi format fill line (MFFL) for our biopharmaceutical and medical device client in Waterford, initial 12 month contract on offer. The PROCESS ENGINEER will ideally have experience in Equipment qualification, cycle development and tech transfer activities, and will support technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Role of this position

  • Support Qualification of new equipment into commercial manufacturing
  • Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
  • Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools
  • Monitoring and review of equipment cycle trends using PI application
  • Assist in the implementation of capital projects
  • Implement and monitor performance metrics.
  • Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams.
  • Lead cycle time reduction initiatives in conjunction with manufacturing teams
  • The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
  • Lead Process Engineering tech transfer activities for product introduction / transfer to the MFFL Line.
  • Provide engineering support to other areas of the MFFL process such as Dispensing, Formulation, Autoclaving and Washing.
  • Provide technical support to implement process improvements, new product transfers to the site and production.
  • Design and implement Process development programs through plant trials, execution and change implementation
  • Constantly seek to challenge operational standards and driving continuous improvement.

JOB REQUIREMENTS

  • Honours degree in an Engineering discipline.
  • Strong problem solving skills.
  • 3 or more years' relevant experience in a highly regulated GMP environment.
  • Experience of Sterile Manufacturing Operations would be an advantage.
  • Experience in syringe filling would be a distinct advantage.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie