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CSV Engineer

Job description

As a CSV Engineer your role will be guided by the Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports. For that, your main duties will be:
• Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards. 
• Assure that all validation test procedures are in line with current technology, corporate and governmental regulations. 
• Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards 
• Review and Approve validation protocols and assessments from a quality system documentation perspective. 
• Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues. 
• Participate and communicate as required in project activities. 
• Develop procedures to manage computerised systems where required 
• Develop and present project plans to project management senior staff 

Qualifications: 
The Next CSV Engineer must have a Bachelor of Science or an Engineering degree or equivalent. Knowledge of cGMP’s and other worldwide regulatory requirements. For that position 2 years experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries are required. As well as experience in cGMP Regulated Environment, working knowledge of GAMP software development lifecycle and computer system validation lifecycle.

 

As a CSV Engineer it is necessary to have problem solving ability and excellent oral and written communications skills.

 

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