MES Engineer

Job Title: MES Engineer
Location: Bothell, WA
Duration - 1-year duration, possibility to extend or convert.

Pay range: $70 - $77/hour. on W2.
H1 transfer can be considered.
No C2C

Top Skills:

• Experience with Emerson Syncade MES and 21CFR Part 11 or other GMP validation settings,
• This includes authoring and executing validation protocols and software development lifecycle management.
• Experience with HTML, XML, VBScript, SQL, or other programming languages accepted.
• Self-starter and driven to find solutions
• Strong ability to work independently and manage their projects/tasks

PURPOSE AND Product 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.

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 BarTender 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

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