MES Change Specialist

Spectraforce Technologies, Inc.; Hillsboro (OR); On-site; USD 95,000 - 130,000; Full time

Job summary

Spectraforce Technologies, Inc. is hiring an MES Change Specialist in Hillsboro, OR to drive design, test, validate, and maintain electronic documentation for operations in a highly automated pharmaceutical facility.

You will lead change management for MES changes, coordinate testing plans, and work with IT/OT, master data, and other departments to ensure compliant, high-quality MES configurations across processes.

Qualifications

• 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.
• Experience with construction, testing, and validation of computerized systems.
• Extensive experience with electronic change management systems to own changes and coordinate action items across departments.
• Experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP) in a regulated industry.
• Strong understanding of test requirements for electronic data systems for regulatory compliance.
• Knowledge of SAP, MES, PLC and HMI within automation environments.
• Experience with sterile pharmaceutical manufacturing processes is preferred.
• Ownership of changes in a change management system (e.g., Veeva) from initiation to closure.
• Experience troubleshooting Rockwell systems, on-site or remote support preferred.
• It is preferred you have experience on EBR or MES deployment projects.

Responsibilities

• Troubleshoot and identify resolutions for mechanical or automation related failures in production.
• Lead user requirement gathering for operational needs and assess MES modification requirements.
• Own CSV functions including defining requirements, writing and executing test scripts.
• Translate operational requirements into recipe and workflow requirements for CSV testing.
• Develop, author, and execute CV and FV testing protocols for MES recipes and workflows.
• Investigate and assess exceptions and deviations from CV and FV protocol testing.
• Plan, execute, and improve review of MES changes for assigned manufacturing processes.
• Monitor project schedule and elevate concerns to leadership with mitigation time.
• Draft test plans for MES changes and comprehensive test reports for new recipes.
• Own MES-related deviations and ensure corrective actions resolve issues.
• Support MES components of site initiatives, capital projects, tech transfers, DS/DP changes, shutdowns, and launches.
• Serve as an audit support for MES, including demonstrations, presentations, and regulatory findings closure.

Skills

Change management

CSV/CSA

GAMP

Regulatory compliance

Documentation writing

Cross-functional collaboration

Analytical troubleshooting

Data analytics

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

SAP

MES

PLC

HMI

Rockwell

Job description

Title: MES Change Specialist

Duration: 7+ months (Possibility of extension)

Location: Hillsboro, OR

Description

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 elevate 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.