MES Change Specialist

Tailored Management; Hillsboro (OR); On-site; USD 92,000 - 96,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

EAP

Job summary

Tailored Management in Hillsboro, OR is seeking a MES Change Specialist for a fully onsite role in a state‑of‑the‑art pharmaceutical environment. You will collaborate with manufacturing, IT, and quality teams to design, test, and maintain electronic documentation and MES changes across operations.

The ideal candidate holds a degree with 3–5 years of MES/EBR experience, plus hands‑on expertise with TrackWise and Veeva, and will own change management activities and CSV testing protocols.

Qualifications

• Bachelor's or Master's degree in a relevant field with 3–5 years MES/EBR experience.
• Experience in construction, testing and validation of computerized systems.
• Experience with electronic change management systems (TrackWise, Veeva) across departments.
• Knowledge of SAP, MES, PLC and HMI in automation environments.
• Experience in sterile pharmaceutical manufacturing.
• Ownership of changes in a change management system (e.g., Veeva) from initiation to closure.
• Troubleshooting Rockwell systems; remote or on-site support.
• EBR/MES deployment project experience preferred.

Responsibilities

• Troubleshoot mechanical or automation failures in production.
• Analyze data to identify opportunities for cost reduction and efficiency gains.
• Lead user requirements and assess MES modification needs.
• Own CSV functions including test script definition and execution.
• Translate operational needs into recipe/workflow requirements for CSV tests.
• Develop, author, and execute CV and FV test protocols for MES recipes.
• Investigate deviations from CV and FV testing.
• Plan and review MES changes across manufacturing processes per change control.
• Monitor project schedule and escalate concerns to leadership.
• Draft test plans and comprehensive reports for new recipes.
• Own MES deviations, ensuring effective corrective actions.
• Support MES components of capital projects, tech transfers, DS/DP changes, shutdowns, launches.
• Serve as audit support for MES; respond to regulatory findings when required.

Skills

MES knowledge

Electronic Batch Records

Change management

CSV validation

Rockwell troubleshooting

SAP knowledge

Education

Bachelor’s degree in a relevant field

Master’s degree in a relevant field

Tools

TrackWise

Veeva

Rockwell

Job description

MES Change Specialist

Working Model- Fully Onsite

Location- 4625 NE Brookwood Parkway Hillsboro OR USA 97124

Contract Duration:8+ Months (Potential for Extension or Full-Time Conversion)
Pay Rate:$67.61-$69.93/hr (W2) Based on Experience
Benefits:Weekly Pay, Medical, Dental, and Vision Insurance

Job 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.

Job Duties:

• 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 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 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 are you:

• 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

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

• Medical Coverage– HDHP, PPO, and Surest plan options
• Minimum Essential Coverage (MEC)
• Dental Insurance
• Vision Insurance
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Life & AD&D Insurance
• Critical Illness Insurance
• Accident Insurance
• Employee Assistance Program (EAP)