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October 23 2018

    Job details


Job description:

   » Job ID.:15396238
   » Employer ID.:RI/PETD07260
   » Published:12-OCT-2018
   » income:NEGOTIABLE
   » Job location:GALWAY, GALWAY
   » Employment Type:PERMANENT


PE Global are currently recruiting for a Computer Systems Validation (Associate Engineer) for one of our Medical Device clients located in Galway. This is a permanent function offering great benefits and a competitive income.
Reporting to the Senior Validations Engineer the Computer Systems Validation AE will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions

The main responsibilities are:
   » Coordinates and communicates all testing with affected functional groups and evaluates test results.
   » Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
   » Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
   » Develop and communicate requirements for quality performance, continuous improvement infrastructure for critical software installations.
   » Write validation plans, reports and procedures.
   » Execute manual tests for software and system validation. Carefully analyse and document test results.
   » Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests. Ensure validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate.
   » Coordinate and participate in the development, testing and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software.
   » Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage. Requirements:
   » Requires a Level 8 or higher degree in an engineering or science discipline with a minimum of 2-3 years of related practice (medical device/pharma preferred).
   » practice in medical device/pharma industry in the development and deployment of quality systems, process controls and continuous improvement systems.
   » expertise or GAMP5, FDA (21CFR11), ISO, PDMA
   » expertise and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control.
   » MS Office competency demonstrated.
   » Able to management multiple projects with competing schedules.
   » expertise of software development methodologies.
   » expertise of ERP, database systems and architecture.
   » expertise of PLC programming methodologies and systems.
If you are interested in this position, please forward your CV to or call 0214297900 . Alternatively please feel free to connect with me on LinkedIn

Although Information technology is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other appropriate positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
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Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Galway
Company Type Employer
Post Date: 10/12/2018 / Viewed 3 times
Contact Information
Company: PE Global
Contact Email:

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