Validation Engineer - Computer Systems

Ref No. EMP459280
Location Middlesbrough, England
Job type Permanent
Job Status Closed
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Introduction

Validation Engineer required for a permanent opportunity based in either Middlesbrough or Warrington (wfh initially) paying up to 42k

Matchtech Job

Important

Validation in one or more of the following areas (Computer System/Process/Project/Equipment/Cleaning etc.)

The Job

Validation Engineer required for a permanent opportunity based in either Middlesbrough or Warrington (wfh initially) paying up to 42k

Working for a specialist systems solutions organisation, you will strive to understand the customer's problems, and key drivers for the changes that are to be made and ensure that you deliver the work on time and in a way that helps the customer resolve their issues.

You will be working across some of the organisations most valued customers' manufacturing sites - taking responsibility for ensuring that manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements, GMP and regulatory requirements.

Key responsibilities:

  • Assist PM in developing the relationships within the customer's site to help build business with them
  • To ensure that project deliverables are issued on time through effective and sometimes innovative utilisation of the Project Team's time and skills.
  • To supervise and monitor the customer's suppliers in delivery of suitable equipment on time, to the relevant pharmaceutical standards.
  • To identify opportunities for improvement in efficiency and usability of the companies Quality Management System
  • To identify training opportunities in self and other ITS staff in the team on site
  • To assist and in some cases run internal projects when back in the ITS office to bring about the changes required.
  • Where required issue weekly and monthly reports to customers with updated Project Gantt charts or other plans
  • Modify, review and create Validation Documents, Quality Plans, Specifications, Test Specifications, Validation Reports
  • Carry out Assessments of computerised systems to ensure that specifications and current regulations are met.
  • Keep abreast of current Computer Validation related regulations
  • Carry out system testing against specifications, record test results and review test results in line with current validation regulations.
  • Work within the regulations required for Pharmaceutical projects and manufacturing, e.g. GMP, GAMP.

Essential Skills

  • You'll have working knowledge in Validation in one or more of the following areas (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).

Desirable skills

  • Any of the following skills/experience - cGMP, GAMP and GxP knowledge with knowledge of FDA 21 CFR Part 11, Annex 11 and Data Integrity regulations will help greatly.

Networkers acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.

Gattaca Plc provides support services to Networkers and may assist with processing your application.

You can not apply for this job as its status is Closed.
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Laura Bennett
manages this role


 

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