MES Change Specialist — Pharma Manufacturing & CSV

Spectraforce Technologies, Inc.; Hillsboro (OR); Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Change management

CSV/CSA

GAMP

Regulatory compliance

Documentation writing

Cross-functional collaboration

Analytical troubleshooting

Data analytics

Formation

Bachelor's degree in a relevant field

Master's degree in a relevant field

Outils

TrackWise

Veeva

SAP

MES

PLC

HMI

Rockwell

Description du poste

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.