Experienced CSV engineer required
Rockbrook Technologies is on a journey to automate processes, systems and buildings in the life science sector and we would like you to join us. We are currently looking for an experienced CSV engineer with at least 5 years experience in a cGMP regulated environment. Working knowledge of GAMP software development lifecycle and computer system validation lifecycle is essential. This role will be based on a client site in the Dublin area. If you feel it’s time for a new challenge please get in touch with your CV.
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.
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.
The successful candidate will have a least 5 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
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.