Job Title: MES Functional Consultant (Rockwell FactoryTalk PharmaSuite)

Location: Remote

Job Type: Contract / Full-Time

Experience: 8+ Years

Role Overview
We are seeking an experienced MES Functional Consultant with strong hands-on expertise in Rockwell FactoryTalk PharmaSuite to support pharmaceutical manufacturing operations. The role involves configuring, maintaining, and enhancing the MES platform while working closely with manufacturing, quality, and IT teams in a GMP-regulated environment.

Key Responsibilities

Configure, maintain, and support Rockwell FactoryTalk PharmaSuite MES for pharmaceutical manufacturing operations
Develop and modify master batch records, electronic batch records, recipes, and workflows
Gather business requirements from manufacturing and quality stakeholders and translate them into MES functional specifications
Support MES integration with ERP, LIMS, SCADA, PLC, historians, warehouse systems, weigh-and-dispense systems, barcode systems, and equipment interfaces
Participate in MES design, configuration, testing, troubleshooting, deployment, and post-go-live support
Support GMP validation activities including URS, FRS, DS, risk assessments, IQ/OQ/PQ, test scripts, traceability matrices, change controls, deviations, and validation summary reports
Manage recipe lifecycle, change management, user access, and role-based permissions

Required Skills & Qualifications

8+ years of experience in MES functional consulting within the pharmaceutical or life sciences industry
Strong hands-on experience with Rockwell FactoryTalk PharmaSuite MES
Deep understanding of pharmaceutical manufacturing processes and batch management
Experience developing and managing master batch records and electronic batch records
Proven ability to write functional specifications based on business requirements
Hands-on experience with MES integrations (ERP, LIMS, SCADA, PLC, historians, and shop floor systems)
Strong GMP validation experience (URS, FRS, DS, IQ/OQ/PQ, risk assessments, traceability matrices)
Experience with recipe lifecycle management and change control processes
Excellent communication and stakeholder management skills

Nice to Have

Experience with other MES platforms (Siemens Opcenter, Werum, PAS-X, etc.)
Knowledge of pharmaceutical serialization and track-and-trace systems
Experience in FDA or EU regulatory audits
Certified in Rockwell Automation MES solutions

Aspire IT Solutions is an equal opportunity employer.
All applicants must submit accurate information; misrepresentation may disqualify candidacy.
This role may require background checks/work authorization verification.
Rate/benefits are negotiable.
Aspire IT Solutions reserves the right to modify or withdraw this posting.

MES Functional Consultant

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