Validation Engineer

2022-05-13 12:10:552050-02-20Team Horizon
Job TypePermanent
LocationSligo
AreaSligoSligoIrelandSligo
SectorQualityRegulatory
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2463
Job Views314
Description
Validation Engineer – Team Horizon
 
We are currently recruiting an ambitious and experienced Validation Engineer to join our client’s Validation team in Sligo. Reporting directly to the Validation Team Lead, you will be responsible for coordinating the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.
 
Why you should apply:
  • Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
 
What you will bedoing:
  • Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance of the Validation Master Plans.
  • Generation of validation plans, protocols, and final reports to cGMP standard.
  • Review / approval of all protocols and final reports.
  • Management of validation change control process.
  • Adheres to and supports all EHS & E standards, procedures, and policies
  • Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines.
  • Close contact with internal and external auditors, e.g. FDA, HPRA.
  •  
What you need to apply:
  • Third level qualification in relevant engineering or scientific discipline
  • A minimum of 2 years’ experience in cGMP regulated environment
  • A good understanding of regulatory requirements
 
 
 
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Darcy Ainscough-Denton
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