Position: - IT Services-MES Engineer
Location: - Bothell, WA 98021
Duration: - 12 Months

Purpose and scope of position (position summary):

• The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES).
• This role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional departments.

Qualification requirements (Knowledge, Skills, and Abilities): Education:
Bachelor s degree or equivalent experience.
Experience:

• 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.
• Strong technical writing competency and GMP procedure writing.
• Strong interpersonal skills to work with teams in different functions and organizations.
• Experience with Emerson Syncade MES and 21CFR Part 11 or other GMP validation setting,
• This includes authoring and executing validation protocols and software development lifecycle management.
• Experience with HTML, XML, VBScript, SQL, or other programming languages accepted.

Preferred Qualifications:

• Experience with SQL and XML coding in a MES construct.
• MS Windows Server and SQL server also a plus.
• Experience with cell therapy or other biopharmaceutical manufacturing. Other highly regulated industries will be considered.
• Flexibility to work within manufacturing schedules.
• Experience with Bar Tender label development.
• Experience with MES-ERP integrations.
• Experience with new process and product deployments within a MES.

Roles and Responsibilities:

• Collaborate with Manufacturing, Supply Chain, Quality, Facilities and Tech Transfer departments, capturing and documenting detailed requirements.
• Perform application support duties for the manufacturing execution system (MES) as needed.
• Develop standards and best practices for development and validation activities!
• Lead cross-functional teams through design reviews and user acceptance testing during the development and validation process.
• Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification.
• Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed software solutions.
• Develop MES solutions including recipe, configuration and/or system changes to meet business requirements.
• Create and execute system test and/or operational qualification scripts to challenge the business and technical requirements!
• Participate in facility operational meetings to ensure facility reporting needs are met.
• Provide mentorship and training for new MES recipe developers.
• Assure quality customer service to all customers.
• Position also requires availability to be on call off shift hours, based on a rotating schedule, to support manufacturing operations.