Job Type: Contract
Job ID: JO-2106-27262
Consultant: Karen McHugh
Are you a CSV Engineer with 5+ years experience working in a cGMP Regulated Environment?
If you have the relevant experience, send your CV to firstname.lastname@example.org or call Karen on +353 17978720 for a confidential chat.
CSV Engineer - BioPharma - Dublin
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.
Candidates must have at least 5 years’ experience in:
- cGMP Regulated Environment
- Computer system validation lifecycle
- Working knowledge of GAMP software development lifecycle
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.
5+ years’ experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries.
Experience using a paperless validation system such as HP ALM
Experience in the validation of one or more of the following system types from project conception to delivery; DCS/SCADA/MES/Historian
Excellent contract rates
Long term contract
Karen McHugh is the consultant managing this position.
If you are a CSV Engineer interested in roles based in Dublin, you can contact Karen by e-mail at email@example.com or phone +353-1-7978720 for a confidential chat.
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