Process Validation Engineer

London (Greater)
10 Jan 2018
09 Feb 2018
Contract Type
Full Time
Are you a Process Validation Engineer interested in working in Hertfordshire?

A Rapidly growing Bio-Pharmaceutical company requires a Process Validation Engineer to join their £15m investment project.

The Client requires an individual for an initial 6-month contract to be responsible for the management of the qualification of process validation within a highly regulated Biopharmaceutical manufacturing environment during a significant period of projects.

Key Responsibilities:
  • Project manage Process validation activities within a highly regulated biopharmaceutical manufacturing environment; specific focus will be on Downstream – Filtration/Ultrafiltration processing.
  • Undertake process validation exercises and/or the supervision of these exercises.
  • Co-ordinate with other groups with responsibilities for process/cleaning validation activities directly related to validation, e.g. Project Engineering.
  • Provide up to date information to Line Management on activities and timelines relating to validation work, utilising appropriate techniques.
  • Write and review process validation protocols and reports for new and existing equipment.
  • Review/produce supporting validation documentation, as required, as part of a validation exercise.

Ideal Skills and Experience:
  • Degree qualified in an Engineering based subject or related experience in a Process Validation role.
  • Experience within Biopharmaceutical Manufacturing environments with a specific background in Downstream (Filtration/Ultrafilters) and Sterile or Aseptic environments.
  • Solid experience of project lifecycle validation activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
  • Demonstrable experience in drafting, executing and delivering process validation strategies.
  • Experience of working alongside regulatory auditors, liaising with FDA and/or MHRA investigators during audits.
  • Ability to train and operate within a sterile manufacturing facility to include aseptic areas.
If this would be something of interest to you please apply now!
This job was originally posted as