Overview
On Site
Full Time
Skills
Test Scripts
Testing
Change Request Management
Root Cause Analysis
Corrective And Preventive Action
Risk Assessment
Documentation
Manufacturing
SOP
GMP
Communication
Leadership
MES
VBA
Job Details
Responsibilities:
- Recipe Authoring using Syncade MES.
- 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).
- ssist the Quality department with deviation investigations.
- ssist with completion of CAPA actions.
- Participate in quality risk assessments. Documentation.
- Review/revise automation and Manufacturing related SOP's, Functional Specifications, and work instructions, equipment/process changes, error prevention activities, etc.
- uthor and review test protocols.
- Perform other duties as assigned.
- Bachelor's degree in engineering or related discipline.
- Related work experience in a GMP environment.
- Strong communication and leadership skills.
- bility to secure relevant information and identify key issues and relationships from a base of information.
- bility to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.
- bility to fulfill on-call hours requirements.
- MES Syncade Recipe Authoring experience.
- VBA coding or Interface experience is plus.
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