CSV Engineer

  • Contract
  • Carlow

Website Ref: TPM04222

Summary:
A CSV Engineer is required for a biopharmaceutical company in Carlow.

Responsibilities:

  • The CSV Engineer will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects managed by Global Engineering Solutions (GES).
  • This candidate will be required to work closely with the client teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
  • Partner with local project teams to deliver Automation and IT aspects of
  • Laboratory capital projects.
  • Liaise with site AIT group to add input to site SOP’s for lab systems.
  • Author\Review\Approval of qualification documents for lab systems – RS, CS, RTM etc.
  • Work with site teams on generation of requirement and\or configuration specification and IOQ test protocols.
  • Participate in execution of IOQ protocols for lab analytical instruments where required.
  • Generate any automation change control documentation required for introducing new systems or modifying existing systems for the QO Lab.
  • Generate any risk assessment\variance documentation and interface with above site team to close out same.
  • Work closely with the QAIT function to ensure compliance with Quality standards.
  • Interface with above site teams for deliverables of Enterprise systems such as Empower, NuGenisis, Acronis etc.
  • Ensures that SDLC is appropriately applied.

Qualifications & Experience:

  • BS in Engineering, Computer Science, or other technical degree.
    3 or more years of experience in project/automation/IT support in a similar role with experience in laboratory analytical instrument qualification.
  • Excellent facilitation, problem solving, and decision-making skills.
  • Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
  • Proven facilitation, meeting/workshop management, project management and change management skills are essential.
  • Excellent written and oral communication skills, as well as strong presentation skills.
  • Experience with Laboratory systems such as LIMS, Empower and Nugenesis.
  • Experience in automation equipment used in Laboratory an advantage.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.