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Equipment Validation Engineer - MAYO

Cpl Resources

  • Galway / Mayo / Sligo
  • Negotiable
  • Permanent full-time
  • Updated 24/10/2017
  • Annette Mullally
this job is expired
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Description

Opportunity in Mayo for an Equipment Validation Engineer to join leading manufacturing company.

 

Opportunity in Mayo for an Equipment Validation Engineer to join leading manufacturing company.

The Role:

  • Process Validation against Corporate SOP/FDA/EMEA requirements.   
  • Accountable for writing, executing & reporting validation documentation (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
  • Execution and documenting of process risk assessment / failure mode and effects analysis.
  • Statistical analysis of data to determine process capability through Cpk and other statistical techniques.
  • Performing of validation functional testing as required.
  • Track and resolve exceptions during qualification activities.
  • Partcipate in cross functional teams.
  • Ensure all information is recorded correctly and compliant with GDP.
  • Assist in execution of validation protocols.
  • Development of project plans to validate processes.
  • Validation projects will be across a range of production areas which may include automation, filling, mixing, cleaning, software, utility and facility projects.

Requirements:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Min 3-5 years experience in validation in an automated/pharma manufacturing environment.
  • In-depth knowledge of validation processes.
  • Knowledge of Pharma/Medical product manufacturing, especially automated processes or filling operations.
  • Project Management skills.
  • Excellent interpersonal, communication & technical report writing skills
  • Experience in process, software, filling and automation process validation.
  • Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.
  • Experience with Minitab or similar stastical package.
  • Ability to understand manufacturing processes.
  • Must be flexible and able to manage multiple priorities simultaneously.
  • Experience in FDA or IMB regulated manufacturing.

Interested candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to

Ref: JO-1710-361903
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