MES Change Specialist

Sharp Decisions; Hillsboro (OR); On-site; USD 82,000 - 116,000; Part time

Job summary

Sharp Decisions is seeking an MES Change Specialist for a 6-month on-site contract in Hillsboro, OR. You'll own CSV validation, MES configuration, and CV/FV testing, collaborating across IT/OT, P&C, and manufacturing to ensure compliant electronic batch records.

Strong TrackWise and Veeva experience, plus knowledge of SAP/MES/PLC/HMI, are essential. Onsite support for sterile processes and regulatory readiness is expected.

Qualifications

• Bachelor's or Master’s degree in a relevant field with 3–5 years MES/EBR experience.
• Experience constructing, testing, and validating computerized systems.
• Prior use of TrackWise and Veeva for change management and CSV.
• Background in IT/OT, quality systems, and validation (CSV/CSA, GAMP).
• Knowledge of SAP, MES, PLC, and HMI in regulated manufacturing.
• Experience with sterile pharmaceutical manufacturing is a plus.

Responsibilities

• Troubleshoot automation and mechanical failures in production.
• Leverage data analytics to improve performance and reduce costs.
• Lead user requirements for MES changes and assess CSV/validation needs.
• Own CSV functions, write tests, and execute validation activities.
• Translate requirements into CSV/test protocols for CV/FV testing.
• Develop and execute CV/FV test protocols for MES recipes/workflows.
• Investigate deviations from CV/FV testing and document outcomes.
• Plan and review MES changes across manufacturing processes.
• Monitor project schedules and escalate risks timely.
• Draft test plans for MES changes and new recipes; produce reports.
• Own MES deviations and ensure corrective actions are effective.
• Support MES in capital projects, tech transfers, DS/DP changes, shutdowns.
• Provide MES audit support and regulatory finding closures when needed.

Skills

MES systems

CSV/CSA

Electronic batch records

TrackWise

Veeva

Change management

Rockwell troubleshooting

Automation knowledge

Education

Bachelor's degree

Master's degree

Tools

TrackWise

Veeva

SAP

Rockwell Automation

Job description

Location:Hillsboro, OR – 100% Onsite
Duration: 06 months contract with possible extension
Payrate:$71.94/hr on W2

****(Looking only local candidates in Hillsboro, OR ||| Only W2)***

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 electronic documentation for operations across HTO.

In addition to performing the responsibilities and tasks below, the successful candidate will need to demonstrate the following traits and capabilities:

• Troubleshoot and identify resolutions for mechanical or automation-related failures in production.
• Identify opportunities to improve performance by leveraging data analytics of system performance to reduce costs and increase efficiency.
• Lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications.
• Own Computerized System Validation (CSV) functions, including defining requirements, writing test scripts, and executing tests.
• Translate operational requirements into recipe and workflow requirements that define CSV test protocols.
• Develop, author, and execute 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.
• Own, plan, execute, and improve the review of MES changes for assigned manufacturing processes through the change management process, including testing and implementation.
• Monitor project schedules and escape concerns to leadership in sufficient time to mitigate risks.
• Assist with drafting test plans for MES changes, including comprehensive test plans and reports for new recipes.
• Own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects, and ensure corrective actions resolve issues effectively.
• Support MES components of other site initiatives, including capital projects, technology transfers, Drug Substance (DS) and Drug Product (DP) changes, shutdown projects, and new launches.
• Provide audit support for MES by delivering demonstrations and presentations and answering questions as required. Where relevant, support the closure of 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 in regulated manufacturing, or a Master’s degree in a relevant field.
• You have prior experience with the construction, testing, and validation of computerized systems.
• You have extensive experience working with electronic change management systems such as TrackWise and Veeva to own changes and coordinate action items across multiple departments.
• You have prior experience in IT, OT, software technical writing, quality systems, and validation (CSV/CSA, GAMP), preferably in a regulated industry.
• You have a strong understanding of electronic data system testing requirements for regulatory compliance.
• You have knowledge of automation systems, including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human-Machine Interfaces (HMI).
• You have prior experience with sterile pharmaceutical manufacturing, including solution preparation, equipment preparation, liquid and lyophilized vial filling, prefilled syringes (PFS), formulation, inspection, and packaging.
• You have experience owning changes in a change management system, such as Veeva, from initiation through closure.
• You have experience troubleshooting Rockwell systems, including remote or on-site support. This experience is strongly preferred.
• You preferably have prior experience with electronic batch record (EBR) or MES deployment projects.