MES Engineer

About ICI

Innovative Consulting Inc. is a global software and engineering consulting firm providing professional services in: Automation, Manufacturing Execution Systems (MES), and Smart Manufacturing. With combined 20+ years of experience in cGMP and FDA regulated industries, our growing and dedicated team of engineers continue to deliver innovative automation related solutions and expertise to plan, design, implement, and maintain projects in alignment with industry standards. We provide professional support and companionship for consulting services, project governance, and accelerating customer solutions in Automation, Manufacturing Systems & Information Technology. We provide client services that include Automation & IT Strategy, Concept Design, Project Execution, Service & Support, Life Cycle Planning & Optimization Services.

Responsibilities:

Manufacturing Execution System (MES) (PharmaSuite) recipe authoring and software

development

Troubleshooting plant floor MES execution and business system integration issues

Compliance with corporate and site business processes, valid design principles, and quality

procedures

Qualification test plan development/review/approval and execution

Implementing production tech transfer requirements into MES system

Knowledge on batch record structure and exception handling, with sharing among the

broader project team and affected site personnel

Understanding of the Core practices that need to be adopted at the site, including recipe

requirement documentation, validation, project deliverables such as project and

implementation plans, etc.

Development of recipe and workflow requirement specifications, formal design

specifications of system master data configuration.

Create, as directed by client, project-specific documentation required for

implementation.

Creation and finalizing recipe requirement specifications for all recipes and workflows

Contributing to the development and optimization of departmental and site business

processes

Provide Consulting with Business Process owners in the Value Streams

Contribute with MES Recipe Authoring knowledge to Projects/Squads for MES Projects,

process improvement initiatives or support

Qualifications

A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent

5 to 7 years of manufacturing execution systems experience, preferably

PharmSuite

Must be able to plan and perform testing, including documenting test conditions, expected

results, and test validation

Must be comfortable working under pressure, delivering quality results with schedule

deadlines and have a proven track record in meeting schedule for tasks while still meeting or

exceeding business requirements and goals

Work autonomously direct with Engineering and Value Streams

Work with Global Recipe Authors Team on common templates for PharmaSuite MES

Strong interpersonal communication skills and Project management skills