Are you a Process Validation Specialist? Then LSC have an exciting role that would be right for you. Our multinational biotech client based in Dublin is looking for an experienced Process Validation Specialist to join and support their dynamic biotech design team of specialists.
The Process Validation Specialist will be responsible for:
o To provide process expertise in the area of process validation, including process performance qualification (PPQ) and continued process verification (CPV).
o Working knowledge of typical drug substance unit operations, including upstream cell expansions and bioreactors, harvest operations and downstream chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
o To author and review process validation documentation (protocols/reports), including validation strategies, risk assessments, protocols and reports, including process validation documentation & strategy documents.
The Process Validation Specialist will have:
o Minimum requirement of B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering (5+ years’ experience), or PhD (3 years’ experience).
o Minimum 5+ years’ experience in Technical Services / Process Development / Manufacturing Support / Research with experience in leading process validation projects (PPQ) in a biological bulk drug substance or equivalent manufacturing processes.
o Experience in developing validation strategies, as well as writing validation protocols and reports, (with multi product focus).
o Technical and operational knowledge of multiple unit operations in typical BDS unit operations
o Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
o Ability to present and defend technical and scientific approaches in both written and verbal form.
If you would like to know more about this Specialist Technical Services role, then please contact Kathy at LSC on 021-4777329 or apply directly through this website