Manufacturing – Stability Scientist
fortiraBothell (WA)
Manufacturing – Stability Scientist
Posted 2 days ago
fortiraBothell (WA)
SENIORITY
Senior
About the role
IT SERVICES -MES ENGINEEREmployee Job Title: MES Recipe DeveloperPURPOSE 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
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.
Duties and Responsibilities:
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
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