Katalyst CRO ยท 2 weeks ago
MES Engineer
Indianapolis, IN
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking an experienced MES Engineer with strong Pharma domain experience to support and enhance Rockwell Automation Pharma Suite in a regulated manufacturing environment. The ideal candidate will design, configure, implement, and support the PharmaSuite while ensuring compliance with regulatory standards and collaborating with various teams in the pharma environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Design, configure, implement, and support Rockwell PharmaSuite (FactoryTalk ProductionCentre)
Work closely with manufacturing, quality, validation, and automation teams in a pharma environment
Support batch manufacturing, electronic batch records (EBR), genealogy, traceability, and quality workflows
Ensure compliance with GMP, GxP, FDA 21 CFR Part 11 requirements
Integrate MES with ERP systems (SAP preferred) and automation systems (PLC/SCADA)
Troubleshoot MES production issues, perform root cause analysis, and support plant operations
Support system validation activities (IQ/OQ/PQ) and maintain required documentation
Participate in MES upgrades, enhancements, and rollout to new production lines
Provide Day-1 onsite support and collaborate with cross-functional teams
Qualification
Required
5+ years of experience as an MES Engineer in the pharmaceutical industry
Hands-on experience with Rockwell PharmaSuite / FactoryTalk ProductionCentre
Strong knowledge of Pharma manufacturing processes (Batch, Packaging, Weigh & Dispense)
Experience with GMP, GxP, FDA 21 CFR Part 11 compliance
Strong experience with MES-ERP integrations (SAP preferred)
Working knowledge of SQL and MES databases
Experience with PLC/SCADA integration (Rockwell Automation preferred)
Strong troubleshooting, documentation, and communication skills
Experience in Validation (IQ/OQ/PQ) and CSV
Exposure to ISA-95 standards
Prior experience in regulated pharma manufacturing plants
Preferred
SAP preferred for MES-ERP integrations
Rockwell Automation preferred for PLC/SCADA integration
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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