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VALIDATION ENGINEER

 

Company:

LOTUS TECHNICAL SERVICES
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Job Reference Number

14565299

Client ID:

RI/LTS VE L
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Posted On:

Feb 3 2012

Location:

LIMERICK
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Job Type:

Temporary

Salary:

COMPETITIVE
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Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We are currently recruiting a Validation Engineer for Limerick.

Job Purpose

The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, and systems.

Responsibilities:

· Responsible for ensuring conformance with current equipment, process, and systems validation regulations

· Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.

· Participate in Worldwide equipment, process, and software development.

· Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures.

· Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises.

· Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel.

· Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.

· Responsible for validation activities for NPI’s / product transfers.

· Responsible for Quality Engineering responsibilities of NPI’s / product transfers

· Responsible for implementing/validating new technologies.

· Contribute towards company procedures regarding validations.

· Responsible for conducting periodic review activities concerning the above.

· Ensure HSE is included on all Quality change order procedure.

· All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

Sills, Qualifications and Experience Required

· Degree level qualification in Engineering or Electronics or Equivalent.

· Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.

· Experience in aspects of QA, validation and ISO 13485.

· DESIRABLE: ISO 13485 Lead Assessor qualification

· Excellent Communication Skills,

· Pro-active approach to work

· Team Player , Flexible, High attention to detail

· High level of validation knowledge

· Highly computer literate

· High level of GMP knowledge, work standards, numeracy