This role is part of the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical support to the manufacturing areas within Kent Science Park (KSP) and also the wider jazz network (internal and external CMOs) as required.Ensure production processes are robust through trending of data and continued process verification.
* Providing input into Process Safety assessments.
* Support equipment qualification and process validation activities, including periodic evaluation of systems and processes as part of the validation lifecycle.
* Responsible for generation of documentation required for the above activities: protocols, risk assessments, change controls, and reports. Responsible for training out protocols to production as required.
* Where a Process is external (at a CMO) provide technical input to ensure that documentation complies with Regulatory dossiers and meets the requirements of the Process Control Strategy (CPPs)
* Act as Subject matter expert (SME) for Regulatory, Customer and Internal/ Corporate audits
* Support the successful implementation of approved projects and associated business plans within MS&T and production areas. This will be achieved by:-
o Acting as “client representative” on key projects and approved business plans
o Delivery of all client/group actions in a timely manner to ensure project delivery on time.
o Technical input where required ensuring project success.
o Build strong cross functional relationships internally and externally.
Required Knowledge, Skills, and Abilities
* Experience working in a Pharmaceutical production or development role
* Experience at maintaining operational standards to FDA and MHRA regulatory requirements
* Excellent computer literacy
* Excellent communication skills, including written, presentational and technical writing
* Experience in working in cross functional teams (internally and externally). Develops and maintains positive working relationships with others.
* Experience in statistics – interpretation and trending of data
Required/Preferred Education and Licenses
* A BEng or MEng in chemical/ process engineering would be preferred.
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