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Process Engineer

I8002

Process Engineer required for a Pharmaceutical organisation based in the Leinster area. Primary focus is to support ongoing manufacturing processes and new product introductions.

Category:
Engineer Chemical
Location:
Leinster
Years of Experience Req.:
3 years+
Date Posted:
22/03/2020
Days Remaining:
144
Employment Type:
Contract
Education Level Req.:
Third Level Degree

Process Engineer 

Role Summary:

  • Responsible for providing process, technical, and validation support including ongoing support of manufacturing processes and support for new product introduction

 

Job Responsibilities:

  • Technical support for manufacturing and new product introductions.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support. 
  • Provide technical input by authoring/ reviewing /approving investigations. 
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation. 
  • 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.
  • 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 Kaiz756116.300565en 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.

 

Education/Experience Requirements:

  • Bachelor Degree in Science, Engineering or Biopharmaceutical discipline.
  • Minimum of 3+ years’ experience in a cGMP processing/sterile filling design, start-up or manufacturing environment.
  • Experience in both equipment and process validation experience is desirable.
  • Knowledge of the automation control platform is desirable.
  • Knowledge of FDA and EU regulations pertinent to aseptic processing, in particular, is desirable.
  • Lean Six Sigma and change control methodology experience desired.

 

DPS is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

 

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