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Validation Engineer

I7589D

Validation Engineer required for a Dublin based Pharmaceutical organisation.

Category:
Control Quality
Location:
Leinster
Years of Experience Req.:
3 years+
Date Posted:
03/06/2019
Days Remaining:
45
Employment Type:
Contract
Education Level Req.:
Third Level Degree


Validation Engineer                                             

DPS currently require a Validation Engineer for a Dublin based Pharamceutical organisation. The successful candidate will have a strong background in validation with experience working across some of the following validation areas; equioment, utilities, packaging & cleaning. 

Resposibilities: 

  • Responsible for leading and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and site procedures.
  • Ensuring site Qualifications are executed in adherence with Site Validation Master Plan, Validation Plans & SOPs, and presenting executed Qualifications during internal and external audits.
  • Ensuring that a continuous state of Validation is maintained for site Equipment, Systems and Utilities, including providing Validation input for site Change Controls.
  • Responsible for executing site Periodic Review and Revalidation activities for Equipment, Systems and Utilities.
  • Drafting and executing site Process Validation protocols.

Education/Training/Experience:

  • BS in Engineering or Equivalent.
  • 4years+ of experience in validation or qualification in healthcare or other regulated field.
  • Working knowledge of ISO 13485:2016 or equivalent.
  • Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11, a plus.

 

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