MES Change Specialist

Title: MES Change Specialist
Work Location : Hillsboro, OR, 97124.

Contract Duration : 8 months with Possible extension
Summary:
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.

Responsibilities

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 Bachelors degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Masters 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.