CSV Engineer Ref:1789

Overview

SPGL is a dynamic and well established professional technical services group, operating in a range of market sectors including Bio-Pharmaceuticals, Medical Devices & Diagnostics, Healthcare, Regulated Consumer Products, Chemicals & Mission Critical. We are a responsible, diverse and inclusive organisation, driven by our vision of ‘making quality a way of life’ and a strong desire to achieve more for our customers. We are proud to have a great team of highly skilled, smart professionals who help, care and support both our clients and each other.

Role

  • Project experience with rolling out software packages with Pharmaceutical Manufacturing Validation (CSV) experience.
  • Date Migration activities.
  • Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
  • Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s.
  • Ensures projects (moderate scale & complexity) are managed in conjunction with cGMP regulatory standards.
  • Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements.
  • Provides technical assistance on current US FDA and EU validation requirements.
  • Generates validation documentation (protocols/reports) and aids with the execution of protocols for computerized systems.
  • Responsible for the validation documentation through approval and implementation.
  • Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
  • Investigates/troubleshoots moderately complex validation problems.
  • Develops moderately complex protocols to ensure quality standards.

Requirements

  • Bachelor’s or master’s degree in Science (Chemistry), Engineering or IT.
  • Minimum 5 years’ experience working in a pharmaceutical sector and GMP environment.
  • 2-4 years’ experience in a Computerized Systems validation environment.
  • Strong communication skills.
  • Capable of working independently and learns fast.
  • Able to execute project to plan.
  • Competent knowledge of Computer Systems Validation.
  • Knowledge of validation publications.
  • Full understanding of relevant quality and compliance regulations.
  • Knowledge of cGLP/cGMP/cGCP/21 CFR Part 11/Annex 11 requirements in a regulated environment.
  • Capable of troubleshooting validation issues associated with projects, process Validation Engineer Computerized systems.
  • Fluent English & Dutch.
  • 40 hours weekly commitment.

What SPGL can offer you

We are a people centric company where our staff are the heart and soul of our organisation. If you’re looking for a forward-thinking workplace and see yourself as a dynamic professional, come and join our team and you can expect:

  • Competitive starting salary
  • Excellent private healthcare
  • Pension and life insurance
  • A variety of challenging projects, with blue-chip customers
  • International project assignments
  • Continuous training and personal development
  • Strong career pathway
  • A mix of young and experienced professionals
  • Multi-cultural and caring organisation
  • An equal opportunity employer
  • Regular team building events and social gatherings

For further information on this role please e-mail careers@spgl.eu

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