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The Company –
Scienta are proud to announce that we are teaming up with New Jerseys leading CDMO! Due to a new location being built, they are now on the search for a Director of Validation to join and establish the team.
The role –
This position reports directly to the V.P. of Quality and is ideally suited for a professional with strong background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects – that transform the lives of patients.
· Responsible for validation programs in support of CGMP manufacturing of clinical trial materials and commercial products
· Responsible for facility, utility, and equipment qualification programs
· Responsible for QA role of assay validation
· Responsible for computer system validation (CSV)
· Responsible for process and cleaning validation
· Maintain and update facility wide validation master plan, and individual master plans for various systems.
· Supervisor, mentor validation staff with the goal of building a sustaining validation team
Your Profile –
If this seems like the perfect role for you – click ‘apply now’ or, email a copy of your CV for a private and confidential conversation.