The CSV Engineer will be responsible for development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
You will also be responsible for the below duties;
- Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
- The CSV Engineer will assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- You will ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- The CSV Engineer will review and Approve validation protocols and assessments from a quality system documentation perspective.
- You will 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 and present project plans to project management senior staff
The next CSV Engineer should have Bachelor of Science/Engineering degree ideally with 2+ years’ experience in pharmaceutical or biopharma industry.
You should have a working knowledge of GAMP software development lifecycle and 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.
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