Syncade MES consultant job vacancy

Vacancy expired!

The Sr. Specialist, Process & Technology is responsible for the solution design, on-site technical support.
Troubleshooting and problem resolution, recipe development and change management for the site manufacturing execution system (MES) and
Enterprise Resource Planning (ERP) system. Specialists work with IT, manufacturing, engineering, vendors, and resources supporting boundary systems to deliver changes to MES recipes.
The position requires strong project management skills and coordination with stakeholders. The position works under the guidance of lead team members.
The Process & Technology department supports both the Summit S12 and Warren sites for cellular therapy manufacturing

REQUIRED COMPETENCIES:

Advanced time management skills, including ability to prioritize and manage expectations
Advanced proficiency in Microsoft Excel & Visio
Advanced knowledge of manufacturing execution systems and ERP systems
Intermediate knowledge of qualification and validation requirements in a regulated environment
Intermediate knowledge of GMP manufacturing
Intermediate technical writing skills
Intermediate knowledge of crystal report design
Intermediate knowledge of SQL, VBA, and/or XML
Basic presentation development and delivery skills
Basic knowledge of cGMP regulations
Ability to perform Adhoc database queries
Ability to provide accurate estimates and effectively communicate status of deliverables
Ability to gown into Grade C and D classified environments
Ability to provide on-call support in case of emergent issues
Ability to travel < 10% of time
Ability to work independently for extended periods of time
Ability to work in a collaborative environment

Education and Experience:

Bachelor's degree in a related field from an accredited college or university required.
Minimum of 5 years relevant work experience required, preferably in a pharmaceutical manufacturing environment.
An equivalent combination of education, experience and training may substitute.

DUTIES AND RESPONSIBILITIES:

Responsible for providing manufacturing execution system operational support, documentation, recipe development, and change management.
Maintain MES library of objects and recipes utilized in Manufacturing.
Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.
Convert user requirements and paper Master Batch Records (MBRs) into MES electronic batch record (EBR) recipes.
Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
Execute testing of the recipes in the development environment to ensure functionality.
Manage User Acceptance Testing process for recipe qualification.
Develop and deliver reports from reporting software.
Adhere to GxP regulatory requirements and internal procedures.
Provide technical support by troubleshooting and resolving MES and ERP issues to support manufacturing operations.
Assist with department support model, including 12x7 on-call support rotation.

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