Process Equipment Engineer

  • Contract
  • Meath

Website TPM04681

Summary:
A Process Equipment Engineer is required by a biopharmaceutical company in Dunboyne. The Process Equipment Engineer will work across a cross functional team (project and sustain) to implement appropriate maintenance strategies and technical training on site as it moves from project to sustain phases.

Responsibilities:

  • The primary focus of this role is the implementation of preventative and corrective maintenance of GMP process equipment (Tangential Flow filtration skids, Chromatography skids, Viral inactivation skids, autoclaves, parts washers, bioreactors, and various biopharmaceutical equipment).
  • Act as point of contact for Maintenance Systems.
  • Support process equipment breakdowns and perform initial troubleshooting of issues.
  • Deal with equipment vendors to set up the service level agreements to outline preventative maintenance support and breakdown support.
  • Act as a point of contact between vendors, scheduling and manufacturing for equipment breakdowns.
  • Support Site acceptance testing and qualification activities with primary focus on building SME level of knowledge of the process equipment to support the sustaining of process equipment in a Manufacturing environment.
  • Represent the Maintenance Engineering group at cross functional team meetings for the project delivery.
  • Support the handover of process equipment from project team to the sustaining manufacturing team.
  • Support the reliability team with FMECA and criticality assessments of both instrumentation and GMP process equipment.
  • Provide SME support to the building of any preventative maintenance tasks and spare parts list in the CMMS system (SAP).
  • Own Process Hazards assessment (PHA) actions, support EHS risk assessments, contamination control strategies for process maintenance.
  • Support Autoclave PQ activities and engineering batches.
  • Draft SOP and Work instructions as required.
  • Lead and support equipment related deviations and appropriate corrective actions.

    Qualifications & Experience:

  • The ideal candidate will have a Level 8 degree in Science, Engineering or Equivalent.
  • Min 2-5 years’ experience in BioPharma industry.
  • Experience with single use process system (process skids) and some hard piped systems (Autoclaves, parts washer, and buffer skid).
  • Good working knowledge of DeltaV, OSI PI (ability to build trends and troubleshoot).
  • Experience with SAP PM or equivalent CMMS system (Work order generation workstream and closure).
  • Managing 3rd party vendors and ability to build relationships with various equipment manufactures.
  • Ability to data mine and statistical analysis for both troubleshooting and knowledge building purposes.

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