Process Engineer

  • Contract
  • Carlow

Website TPM04931

Summary:
Our client is a global bio pharmaceutical company with a facility in Carlow, looking for a Process Engineer who will lead/execute production floor-based activities, will participate on a team of engineers, will plan and execute C&Q, validation activities as required, as well as design and develop engineering studies.

Responsibilities:

  • Lead/execute production floor-based activities.
  • Plan and execute C&Q, validation activities as required.
  • Design & develop engineering studies.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment/qualification validation programs; including re-qualification and revalidation.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Statistical data analysis to support development and commercialisation batches.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports.
  • Execution/development of change controls.
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.
  • Implement subsequent corrective action through the change management system.
  • Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance Proprietary.

Qualifications & Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline.
  • Typically have 5 years related work experience in Aseptic manufacturing / process engineering ideally in manufacturing, preferably GMP Setting.
  • Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.

To apply for this job email your details to orla.daly@tandempm.ie.