Cache of job #14019062

Job Title

Validation Engineer

Employer

Careerwise Recruitment

Location

Cork

Description

A Senior Validation Engineer is required for our Cork based industrial automation solutions client.This is a permanent staff role. Please contact Diarmuid Buckley for full details. ROLE: * Development and execution of C&Q and CSV protocols for manufacturing production systems throughout the system development life cycle such as Risk Assessments, Validation/Qualification Plans, User/Functional Requirements, Design Qualification (DQ), FAT/SAT, Testing (IQ/OQ/PQ), Traceability Matrix and Final Reporting on both, legacy systems as remediation efforts and new systems. * Execution of gap assessments and remediation initiatives regarding data integrity for computerized systems within the site, including laboratory as well as production systems. * Understanding and experience with regulations for and Computer System Validation and Commissioning and Qualification such as FDA cGMP's for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ICH 9, ASTM E2500, GAMP5, ISPE C&Q Guidelines 5, 12. * Familiarity and exposure with control systems including Delta V, Foxboro, Siemens S7/PCS7 and Rockwell PLC's, iFIX and Wonderware SCADA system. REQUIREMENTS: * Bachelor's degree in engineering or related science studies. * 5 years of related work experience with strong knowledge and hands-on experience of C&Q and CSV activities in the regulated industries. * Knowledge and experience of API, Bulk Chemicals, Fill Finish, Parenterals, and/or Dry Products processes and technologies. * Familiarity and exposure with control systems including Delta V, Foxboro, Siemens S7/PCS7 and Rockwell PLC's, iFIX and Wonderware SCADA system. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

Date Added

1799 days ago

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