MES Change Specialist

Planet Pharma; Hillsboro (OR); On-site; USD 76,000 - 94,000; Full time

Job summary

Planet Pharma is seeking an MES Change Specialist to design, test, validate, and maintain electronic documentation for operations in a state-of-the-art pharmaceutical facility. You will own MES changes across multiple departments, perform CV/FV testing, and drive change management to ensure compliant, efficient production processes.

The role requires a Bachelor’s or Master’s degree in a relevant field with 3–5 years of MES/EBR experience, familiarity with TrackWise and Veeva, and strong

Qualifications

• Bachelor's or Master's in a relevant field with 3–5 years MES/electronic batch record experience.
• Experience constructing, testing, and validating computerized systems.
• Extensive experience with electronic change management systems (e.g., TrackWise, Veeva).
• Knowledge of SAP, MES, PLCs, and HMI in regulated environments.

Responsibilities

• Troubleshoot mechanical/automation failures in production.
• Identify opportunities to improve using data analytics for efficiency.
• Lead requirements gathering and assess MES modifications.
• Own CSV requirements, test scripts, and execution.
• Translate requirements into recipe/workflow specs for CSV testing.
• Develop, author, and execute CV/FV testing protocols for MES.
• Investigate deviations from CV/FV testing.
• Plan, execute, and review MES changes per Change Management process.
• Monitor project schedules and escalate as needed.
• Draft test plans for MES changes.
• Own MES-related deviations and ensure corrective actions.
• Support MES components of site initiatives (capital projects, tech transfers, DS/DP changes).
• Provide audit support for MES and assist with regulatory findings closure.

Skills

Troubleshooting

Data analytics

Requirements gathering

CSV testing

CV testing

FV testing

Change management

Deviations handling

Project management

Test planning

MES issue resolution

Cross-functional collaboration

Audit support

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

Rockwell

Job 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 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.

Pay Rate Range: 55-68/hr depending on experience