Previous Job
Previous
Emerson Syncade MES Consultant
Ref No.: 21-00263
Location: Summit, New Jersey
PURPOSE AND SCOPE OF POSITION:
  • 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.
Any queries, reach out to Steve - 7603074259 or email to steve@dantatechnologies.net