CSV Engineer

Posted on Apr 17, 2019 by Anonymous

Dublin, Dublin Ireland
Health Care
Immediate Start
Annual Salary
CSV Engineer

Headcount Engineering is seeking a CSV Engineer to join our team at a client's biopharmaceutical facility in Dublin. This is a contract of minimum 12 months duration.

Main 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.

* Develop procedures to manage computerised systems where required

Basic Qualifications:

* Bachelor of Science/Engineering degree or equivalent.

* Knowledge of cGMP's and other worldwide regulatory requirements.

* 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.

To discuss further please contact Mick on (phone number removed) or forward details in confidence to

Reference: 694542440

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