Contractor M&E Validation Engineer

Job Overview

Job Title: M&E Validation Engineer

Type: Contractor / Ltd company

Duration of contract: 18+ months

Location: Co. Westmeath

My client is one of Ireland's leading Contractor who have extensive experience delivering complex projects in Pharmaceutical, Medical Devices, Public Works, Industrial and Commercial sectors.

They have an excellent reputation in the market for both their quality of work but their employee satisfaction. I have placed a number of engineers with this company over the years and every candidate I have place there has been very happy.

They are seeking an M&E Validation Engineer to support their pharmaceutical utilities project in Athlone. €45phr - €50phr

The M&E Validation Engineer shall be responsible for carrying out activities including, but not limited to:

  • Development of C&Q strategy/plans and input to scheduling activities for busy small projects group, in line with site standards for CQV
  • Preparation and review of documents associated with lifecycle of C&Q activities including Validation Master Plans, RVs, IVs, FAT's, Risk Assessments, DQ, IQ, OQ, IC, OC and summary reports.
  • Experience in and/or understanding of:
    • Equipment validation
    • Facilities validation
    • HVAC system validation
    • Cleaning validation
    • Process Validation
    • Analytical method validation
  • Supporting the client in determination of URS's and FRS's and have an understanding of PQ requirements and associated review
  • System / Equipment Classification Reviews
  • Oversight and implementation of the CQV Program, ensuring quality delivery
  • cGMP Reviews
  • Active participation with Client QA group to ensure compliance with procedures and provision of support to the QA Quality team in audit preparation
  • Change Management activities during project lifecycle, ensuring completion and required sign-off
  • Ensuring data integrity and quality culture in all aspects of project execution
  • Summary report writing/ metrics / schedule reviews
  • Oversight and implementation of the client CQV Program, ensuring a quality delivery
  • Interfacing with representatives on project team, Construction, Engineering, Automation, End Users during the different project phases and throughout all levels
  • Understanding of FDA, MHRA requirements, GMP and GEP

Skills

  • A degree in engineering or equivalent.
  • A certificate/diploma in similar areas with appropriate industrial experience
  • Extensive experience of CQV activities in a project environment within the pharmaceutical or biotech industries
  • Ability to work on multiple small projects at different phases of execution
  • Experience of variety of Biological equipment and utility systems
  • Experience with Regulatory and industry standards for GMP and GEP
  • Exhibit excellent quality behaviors
  • Self-starter and good team player
  • Good oral & written communication skills

Apply today by submitting your CV (in Word document) through this website now in the strictest of confidence.

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