Manufacturing – Stability Scientist

Position Details:

Job Title: IT SERVICES
-MES ENGINEER

Location: 22026 20th Ave. SE, Bothell, WA, 98021

Duration: 9 Months (Contract)

Employee

Job Title:

MES Recipe Developer

PURPOSE AND SCOPE OF POSITION:

• The Emerson Syncade Recipe Developer will deliver electronic batch record configuration and validation in the Emerson Syncade Manufacturing Execution System (MES) and provide support for during batch record execution.

Education: Bachelor’s degree or equivalent experience.

Experience

• 2-5 years in computer or science-based field
• Direct experience in Emerson Syncade MES system. Experience in another MES system will be considered.
• Experience with writing and executing validation protocols.
• Technical writing competency and GMP procedure writing

Preferred Qualifications:

• Experience with SQL and XML coding in an MES construct.
• Experience with cell therapy or other biopharmaceutical manufacturing.
• Flexibility to work within manufacturing schedules.
• Strong interpersonal skills to work with teams in different functions and organizations.

• Develop, validate, and deploy new and revised recipes in the Emerson Syncade MES system.
• Perform system configuration tasks and testing with supervision.
• Participate in validation activities including the development and execution of IQ/OQ/PQ protocols and testing.
• Perform dry runs and verification testing.
• Participate in cross-functional teams to assess and communicate planning, development, and testing solutions for recipe creation and modification.
• Perform support of floor operations on a rotational basis.
• Deliver updates to system lifecycle documents such as User Requirements Specifications, Configuration Specifications, Function Specification, Design Specifications.
• Work with local and network IT to develop and deliver holistic solutions in the MES system.
• Participate in cross-functional teams including Manufacturing, IT, and Quality.
• Lead design reviews with internal customers.
• Perform peer reviews of configuration and protocols.
• Complete documentation of development and validation activities