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Manufacturing Execution System
4 months ago
Hybrid (At least 50% onsite) Manager is willing to accept candidates who will relocate at their own expense.
12 Month contract
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.
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
