Execute test scripts (design execution simulation wet testing).
Own change requests and complete change request tasks to support project completion.
Perform change request assessments.
Deviations / Root Cause Analysis (RCAs).
Assist the Quality department with deviation investigations.
Assist with completion of CAPA actions.
Participate in quality risk assessments. Documentation.
Review/revise automation and Manufacturing related SOPs Functional Specifications and work instructions equipment/process changes error prevention activities etc.
Author and review test protocols.
Perform other duties as assigned.
Requirements:
Bachelors degree in engineering or related discipline.
Related work experience in a GMP environment.
Strong communication and leadership skills.
Ability to secure relevant information and identify key issues and relationships from a base of information.
Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.
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