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Job Details

Computer Validation Engineer

Company: Thornshaw Recruitment
Location: Dublin
Reference: LD9270
Closing Date: 09 Jan 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

We are recruiting for a Computer Systems Validation Engineer for a Dublin based, global pharmaceutical company. This is a permanent role and a fantastic opportunity to progress in computer validation.

Requirements:

We are recruiting for a Computer Systems Validation Engineer for a Dublin based, global  pharmaceutical company. This is a permanent role and a fantastic opportunity to progress in computer validation.

You will be responsible for overseeing the validation process for new system installations with the Company’s customers. You will be customer focused and enjoy working in a fast growing and dynamic organization. 

Responsibilities include: 

  • Overseeing the validation process for new system installations. 
  • Generating URS, Validation Plans, Risk Assessments/FMEA’s, FDS, RTMs, Design reviews, validation summary reports, IQ/OQ/PQ validation documentation, Standard Operating Procedures, etc. and executing validation protocols. 
  • Assessing software systems based on GAMP 5 and Gamp 4 guidelines. 
  • Performing Gap analysis against 21 CFR Part 11 and Annex 11 
  • Ensuring that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems 
  • Reviewing and approving of all Computer Systems/Software Validation Documentation. 
  • Adhering to all GMPs, compliance and regulatory mandates and quality requirements.  
  • Positively supporting company audits and inspections and participating in audits and as required. 

Applications are invited from candidates with the following background and experience: 

  • Bachelor’s degree in Science / Engineering 
  • 2/3 years relevant experience 
  • Previous Pharmaceutical / Medical Device industry experience 
  • Experience with quality management systems 
  • Experience of working with multiple stakeholders (technical and non-technical) both on-site and virtually. 
  • Strong communication skills, verbal and written 
  • Experience and interest in working in a fast growing and dynamic team 

Our client is an equal Opportunities employer. 

For more information and to apply for this role please call Lisanne at +353 1 2784671 or email your CV in the strictest confidence to ldelaney@thornshaw.com. 
Log on to www.thornshaw.com for more jobs. 

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.
Www.thornshaw.com Tel: +353 1 2784671

Apply for this job: Computer Validation Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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