Posted on Apr 17, 2019 by Anonymous
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.
* 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
* 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