Manufacturing & Engineering

CSV Engineer

  • TypePermanent
  • Salary€95000.00 - €110000 per annum
  • LocationKildare
  • Published8 Feb 2024
  • Ref#BBBH14060
  • Apply now!

Azon Recruitment Group is delighted to be partnering with a rapidly growing life science organisation to recruit for a Senior CSV Engineer.

This role presents an exciting opportunity to contribute to a rapidly growing company and industry sector, offering potential involvement in shaping future business models. An excellent package, including relocation allowance for EU candidates, is provided for those considering a move to Ireland.

Location: Co. Kildare

Work Model: Hybrid

Key Responsibilities:

  • Client Management: Oversee client CSV activities and foster client relationships.
  • Project Strategy: Define CSV strategies within client project teams guided by the CSV lead.
  • Consultancy Services:Provide front-end consultancy services to support ongoing business development.
  • Document Development: Collaborate on GxP Computerised Systems Lifecycle documents for Lab, Automation, Business, and Equipment systems.
  • Validation Process: Plan, coordinate, and participate in a compliant validation process, adhering to regulatory requirements and company standards.
  • Problem Solving: Investigate and troubleshoot problems, suggesting solutions or improvements.
  • Compliance Enhancement:Identify requirements for compliant computerised operations and propose methods for ensuring and maintaining compliance.
  • Policies and Procedures: Implement policies and procedures for validating/qualifying computerised systems.
  • Validation Protocols:Assist in preparing/executing validation protocols and associated documentation for GxP Computerised Systems.
  • Documentation Review: Review and approve GxP Computerised Systems Validation Documentation.
  • GAMP Lifecycle Administration: Administer the GAMP lifecycle across projects.
  • Reporting: Report project status and activities to the Odyssey VC team lead.

Requirements:

  • Education:
    • Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or related field.
  • Experience:
    • 5+ years of CSV Engineer experience in the Life Sciences industry.
    • Prior experience with cGMPs, GLPs, and Quality Systems.
    • Strong knowledge of data integrity and compliant SDLC based on GAMP 5.
    • Thorough understanding of quality systems, regulatory guidance documents, and standards.

Person Specification:

  • Excellent communication and interpersonal skills.
  • Ability to convey IT/Validation concepts/strategies to project teams.
  • Enthusiastic, energetic, and adaptable to a fast-paced working environment.
  • Self-starter with a flexible and innovative approach to work.
  • Strong integration and interaction skills within the customer environment.

Emma Griffin

Senior Recruitment Consultant - Manufacturing & Engineering

Emma is a Senior Recruitment Consultant who specialises in Manufacturing and Engineering. After graduating with both a Bachelor of Arts and Master of Arts in History and Italian from the National University of Ireland, Galway, Emma started her career in recruitment in 2021. Her experience recruiting in the Healthcare and Luxury Retail space provided her with an insightful approach to understanding individuals' unique qualities whilst also facilitating more meaningful and successful professional matches within teams and organisations. She collaborates closely with both clients and candidates in Ireland’s most reputable firms to build lasting connections across an ever-growing and exciting field of work.

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