CSV Validation Engineer (CIM7120) Dún Laoghaire, Republic of Ireland
Candidates must have at least 3 years’ experience in:
- cGMP Regulated Environment
- computer system validation lifecycle
- working knowledge of GAMP software development lifecycle
See full details below:
Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
• 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
• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMP’s and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills
• Understanding of the computer system validation lifecycle
• Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
• The successful candidate will have a least 3 years experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries