Project Engineer (Temperature and Relative Humidity) Ref:1804

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

In production departments, raw materials are transformed into filled medicines. The product goes through various production steps (weighing, formulation, preparation, freeze-drying, filling, capping, inspection, storage and transport).Manufacturing strives for the highest degree of operational excellence at all steps. Further in the production process, the medicine will be labelled and packaged to then reach our patient via the distribution chain. The position of Project Engineer & RH is situated within the Utilities department. This department is responsible for both the timely validation of devices related to the storage of products (refrigerators, freezers, climate chambers, warehouses, incubators, etc.), and the follow-up of external companies within the site.

As a T&RH Project Engineer you will be responsible for the following:-

  • Planning, monitoring and executing validation studies according to the correct procedures
  • A mix between practical and theoretical work and daily contact with different departments within the site
  • Independently plan, follow up and (to a lesser extent) perform validation studies.
  • Support to the analysts regarding studies/tests belonging to the routine requalification program
  • Drafting, reviewing and approving validation documents (protocols, test scripts and reports).
  • Follow up on deviations.
  • Ownership of the T&RH system with the associated procedures, rationale and FORMS.

Requirements

  • Master’s degree in a scientific direction (Bio engineer, industrial engineer, Pharmacist, Biochemistry or Biotechnology) or equivalent through experience
  • Good knowledge of English (written and oral)
  • Knowledge of cGMP and RFT.
  • Strong interpersonal skills, team player
  • Strong communication skills
  • You work in an organized, accurate and quality-conscious way
  • Analytical skills and problem-solving ability
  • Good technical writing style
  • Experience and/or knowledge of temperature mapping and/or validation
  • Experience in a similar position, quality or production environment
  • Experience in a GMP environment

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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