Senior Process Engineer x2

Carlow  ‐ Onsite
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Keywords

Description

The successful candidate will be responsible for providing process, technical, and validation support including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required. The role is based within the Technical Engineering function.

Key Responsibilities:
Serve as technical support for manufacturing and new product introductions through.
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.
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
Proven experience in a cGMP biopharmaceutical processing/sterile filling design, start-up or manufacturing environment
Excellent report/standard/policy writing skills; required
Experience in process engineering and technologies pertinent to Formulation and Sterile Filling Operations including Media Prep, Buffer Prep, Adjuvant Manufacture, Formulation, Vial and Syringe filling and automated visual inspection; desirable
Experience in both equipment and process validation experience; desirable
Knowledge of the automation control platform; 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
Start date
n.a
Duration
Initially 6 months
From
Quanta Consultancy Services
Published at
09.10.2014
Project ID:
788021
Contract type
Freelance
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