Experienced CSV engineer Required
Rockbrook Technologies are currently looking for a CSV engineer with at least 3 years experience in a cGMP Regulated Environment. Working knowledge of GAMP software development lifecycle and computer system validation lifecycle is a requirement. This role will be based on a pharma client site in the Dublin area. If you feel it’s time for a new challenge, please get in touch with your CV.
You will be involved in the 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.
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.
Candidates should have 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.
Minimum of 3 years of relevant experience in automation roles.
Bachelor of Science/Engineering degree or equivalent.
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.
If you feel you have the experience we require for the role please click on the button below to submit your CV and a member of our team will be in touch with you. Please note all CV’s received are treated with the strictest confidentiality.
Rockbrook Technologies is an equal opportunities employer.