CSV Engineer required for multinational biotech company based in South Dublin. In this role you will be responsible for Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports for Automated Systems.
o Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
o Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
o Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
o Review and Approve validation protocols and assessments from a quality system documentation perspective.
o Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues.
o Participate and communicate as required in project activities.
o Develop procedures to manage computerised systems where required
o Develop and present project plans to project management senior staff
EDUCATION AND EXPERIENCE:
o Bachelor of Science/Engineering degree or equivalent.
o At least 3 years experience in CSV of automated systems in manufuacturing organizations in the biotechnology or pharmaceutical industries.
o 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.
o Knowledge of cGMP’s and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills
Please contact Kathy on 021 4777329 email@example.com for full details of this role or apply directly through this advert.