Computer Systems Validation Engineer Job in Eindhoven, Netherlands

Xelvin is a reliable partner for (international) companies to recruit and employ high educated technical professionals.

Our highly motivated employees are active in a broad variety of areas: mechanical, biomedical, electronic and chemical engineering, research and development, industrial automation and ICT.

Their flexibility and attitude make the difference. They have proven to be easy adapters and fast learners, they prove their productive value very fast.
Xelvin wants to achieve optimal added value for all parties involved. We help companies to find the right balance between their need for flexibility and finding the right person for the job ensuring continuity for the business. For employees we are looking for the most challenging jobs at the best companies in Europe.

Computer Systems Validation Engineer Job Description

Essential Duties and Responsibilities include, but are not limited to, the following:

• Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Lead process improvement projects to improve the validation of computerized systems
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company's computer validation policies.
• Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
• Trains /advises less experienced Specialists and Technicians.
• Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
• Technical writing experience.
• Generation of Validation documents.
• Review and Approval of Validation documents.
• Strong attention to detail and accuracy.
• Experience in risk assessments in relation to validation activities.
• Advise and support all teams on computer validation activities.

Computer Systems Validation Engineer Job Requirements

Education and Experience:Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education.

Experience with process control systems necessary.Interested in the position of Computer Systems Validation Engineer?Send your resume before 21-7-2015 or call our office in Eindhoven at +31(0)040 - 29 10 056.

Computer Systems Validation Engineer Application Information

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Computer Systems Validation Engineer Summary

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