Description
An innovative Biopharmaceutical manufacturer, based in the South-East of England, is currently looking for an experienced Validation lead to oversee the Process/Cleaning Validation activities during a period of significant activity.The responsibilities of the Validation Lead (Process/Cleaning) are as follows:
• 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.
• 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.
To fulfil these requirements for the Validation Lead (Process /Cleaning) you must have the following skills/experience:
• Degree qualified in an Engineering/Scientific based subject or related experience in an 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.
The successful Validation lead (Process/Cleaning) will have the chance to work in a very reputable company within the life sciences industry during a very exciting period of projects and receive competitive rates of pay.