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AL

MES Change Specialist

Artech LLC
  • 🇺🇸 United States
  • On-site
  • 3 days ago
  • Change Management
  • Veeva
  • Technical Writing
  • Regulatory Compliance
  • SAP
  • PLC
  • HMI
  • Shopify Liquid
3 days ago
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Position Details:
Job Title:MES Change Specialist (ROCGJP00043352)
Location:Onsite in Hillsboro, OR 97124
Pay Rate: Up to $70/hr. W2
Duration: 12-15+ Months, strong extension/conversion possibility
 
The Opportunity:As part of the Process and Compliance Team in manufacturing, you will perform a wide variety of tasks and operations that are required to design, build, test, validate, and maintain pharmaceutical production in a state-of-the-art, highly-automated production and packaging facility. The MES Change Specialist works cross-functionally with manufacturing, P&C, ITOT, Master data, and many other departments to ensure the efficient construction and effective functionality of our electronic documentation for operations across HTO.


In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits and capabilities:
  • You will troubleshoot and identify resolutions for mechanical or automation related failures in production
  • You will identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
  • You will lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
  • You will 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
  • You will 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
  • You will monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
  • You will assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
  • You will own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
  • You will support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
  • You will 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.
Who you are:
  • You 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 
  • You have prior experience with construction, testing, and validation of computerized systems
  • You 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.
  • You have a strong understanding of test requirements for electronic data systems for regulatory compliance
  • You have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
  • You 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
  • You 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
 
 


Regards,
Adarsh Singh
Sr. Technical Recruiter
 

Cell:(973) 507-7564
Email: Adarsh.Singh@artech.com
LinkedIn:linkedin.com/in/adarsh-singh-71ba1b1b9
360 Mt. Kemble Avenue, Suite 2000, Morristown, NJ 07960 
Website:www.artech.com

MES Change Specialist · Artech LLC

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