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Computer Systems Validation

Job description

Responsibilities:

  • Participating and developing the validation program onsite, coordinating testing for software and manufacturing process systems onsite in line with cGMPs and industry standards.
  • Aid software system developers and SMEs in designing, documenting, performing and improving verification tests ensuring validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate.
  • Define validation plans with quality department and participate in team projects for installation, validation, troubleshooting and system update activities.
  • Provide information on systems validation to other departments at early stages.
  • Use your knowledge of validation principles and guidelines to help with risk assessments, CAPAs and change controls.

 Requirements:

  • Level 8 or higher degree in engineering, science or similar with 2 to 3 years’ experience in medical device, pharma or similarly regulated environment.
  • Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA
  • Knowledge of software development methodologies.
  • Knowledge of ERP, database systems and architecture.
  • Knowledge of PLC programming methodologies and systems.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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