CSV/CQV Engineer

Posted on Mar 12, 2019 by Vivid Resourcing Ltd

Dublin, Dublin Ireland
Immediate Start
Annual Salary

CSV/CQV Engineer


Initial 6 Month Contract

Rate DOE

Day to Day Responsibilities

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.

Candidates must have at least 3 years' experience in:
- cGMP Regulated Environment
- Computer system validation life cycle
- Working knowledge of GAMP software development life cycle
- Understanding of the computer system validation life cycle

Preferred Qualifications
. Candidates must have demonstrated experience in the delivery and management of IS/Automation systems in addition to a working knowledge of GAMP software development life cycle, 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.

Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.

Reference: 668739549

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