Due to internal promotion we are now looking to recruit a Process Validation Manager who has overseen Change within a Biological Manufacturing Group and has driven improvements in both compliance and efficiency using structured processes and tools such as FMEA, Risk Assessments and who is familiar with making changes in a regulated environment.
To provide leadership to a team (6 in total and 2 direct reports) within the Technical Development Group responsible for ensuring that critical processes & equipment used within manufacturing are used effectively and fully validated.
• Validating new processes, materials or equipment developed either during New Product Development (NPD) or Change Control.
• Evaluate and improve existing processes, materials or equipment used within manufacturing. This may include the identification & the selection of new equipment via the use of process methodologies, risk assessments, FMEA etc.
• To contribute to the process of defining the performance and specification of new products.
• To critically assess raw materials and generate raw material specifications including QC limits for all new components parts.
• To carry out new product feasibility studies, designing working reagents as defined in the New Product Development process.
They will support the transfer of validated processes into manufacturing, including documentation and training to maximize reliability & minimize variability during manufacture.
• GCSE or A Level Maths, GCSE English
• Degree in relevant subject or equivalent experience
• Knowledge of chromatography techniques at multiple scales
• (duplicated below)Experience using FMEAs with complex raw materials (ideally biological raw materials)
• Proven record of driving change / improvement in a regulated industry
• Previous management experience, including performance reviews and training with a track record of developing staff
• Computer literate
• Excellent communication skills, verbal and written
• Knowledge of immunodiagnostic assays
• Previous experience of working in a IVD manufacturing GMP environment
• Project Management skills
- Business Process