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).
• 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 SOP’s, Functional Specifications, and work instructions, equipment/process changes, error prevention activities, etc.
• Author and review test protocols.
• Perform other duties as assigned.

Requirements:

• Bachelor’s 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.
• Ability to fulfill on-call hours requirements.
• MES Syncade Recipe Authoring experience.
• VBA coding or Interface experience is plus.

• 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).
• 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 SOP’s, Functional Specifications, and work instructions, equipment/process changes, error prevention activities, etc.
• Author and review test protocols.
• Perform other duties as assigned