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Process Engineers - Multiple
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineering, Engineer
Projektbeschreibung
Role - Process Engineer x 5
Location - Co. Carlow
Type - start ASAP until end of 2015
Role
The successful candidates will be responsible for providing process, technical, and validation support, including ongoing support of manufacturing processes and support for new product introduction.
Key Accountabilities:
Serve as 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 Kaizen events as appropriate.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues eg 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 Carlow at global technical forums.
Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
Key Requirements:
Minimum qualification B.Sc. or M.Sc./M.Eng Degree in Science, Chemical or Biopharmaceutical or equivalent discipline;
Experience in a cGMP biopharmaceutical processing/sterile filling design, start-up or manufacturing environment
Experience in process engineering and technologies pertinent to Formulation and Sterile Filling Operations
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
Report, standards, policy writing skills required
Lean Six Sigma and change control methodology experience desired
Location - Co. Carlow
Type - start ASAP until end of 2015
Role
The successful candidates will be responsible for providing process, technical, and validation support, including ongoing support of manufacturing processes and support for new product introduction.
Key Accountabilities:
Serve as 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 Kaizen events as appropriate.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues eg 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 Carlow at global technical forums.
Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
Key Requirements:
Minimum qualification B.Sc. or M.Sc./M.Eng Degree in Science, Chemical or Biopharmaceutical or equivalent discipline;
Experience in a cGMP biopharmaceutical processing/sterile filling design, start-up or manufacturing environment
Experience in process engineering and technologies pertinent to Formulation and Sterile Filling Operations
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
Report, standards, policy writing skills required
Lean Six Sigma and change control methodology experience desired
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges