IL
MES Change Specialist
ICONMA, LLC
- 🇺🇸 United States
- On-site
- 19 hours ago
- $66.50 – $71.50 / hour
- Change Management
- Veeva
- Technical Writing
- Regulatory Compliance
- SAP
- PLC
- HMI
- Shopify Liquid
19 hours ago
Responsibilities:
- Troubleshoot and identify resolutions for mechanical or automation related failures in production
- Identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
- Lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
- Own CSV functions including defining requirements, writing and execution of test scripts
- Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
- Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
- Investigate and assess exceptions and deviations from CV and FV protocol testing
- Own plan, execute, and improve review of MES changes for a set of assigned manufacturing processes driven by the change management process, including testing and implementation
- Monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
- Assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
- Own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
- Support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
- Serve as an audit support for MES, providing demonstrations, presentations, and answering questions as required. If topical, support closure of any MES-related regulatory findings.
Requirements:
- Hold a Bachelor’s degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Master’s degree in a relevant field
- Have prior experience with construction, testing, and validation of computerized systems
- Have extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
- Prior experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
- Have a strong understanding of test requirements for electronic data systems for regulatory compliance
- Have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
- Have prior experience with sterile pharmaceutical manufacturing (solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, packaging, etc)
- Ownership of changes in a change management system (ex. Veeva) from initiation to closure
- Have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
- It is preferred you have prior experience on an EBR or MES deployment projects.
- Must have experience working in a manufacturing environment
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
MES Change Specialist · ICONMA, LLC