CSV Engineer

Careerwise Recruitment

Limerick

CSV ENGINEER required by CareerWise Recruitment fopr our multinational BioTech client in Limerick. The CSV ENGINEER will be involved in the generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments e.g. Part11 Assessments, etc. related to IT Infrastructure systems and related IT Applications and system components. THE ROLE: * Prepares/reviews validation documentation related to projects/change controls. * Manages change controls and other compliance related tasks e.g. non-conformances. * Participates in the review of current and future CSV procedures and polices. * Analyzes the results of testing and determines the acceptability of results against predetermined criteria. * Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. * Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation. * Coordinates with other departments or outside contractors/vendors to complete validation tasks. * Participates in regulatory audits and communicates company's computer validation policies. * Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps. * Manages projects and prepares status reports using Microsoft project and other communication tools. RESPONSIBILITIES: * Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5 years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education. * Experience in a GMP environment essential. * Biologics experience highly desirable. Please call Conor Twomey today for further information on 021-4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2191 days ago