MES Change Specialist

Dawar Consulting•Hillsboro, OR

7d•Onsite

About The Position

The MES Change Specialist will join the Process and Compliance (P&C) team at a highly automated pharmaceutical manufacturing and packaging facility. The role supports the design, configuration, testing, validation, and maintenance of Manufacturing Execution Systems (MES) and electronic batch documentation. The specialist works cross-functionally with Manufacturing, Quality, IT/OT, Automation, and Master Data teams to manage MES changes, ensure regulatory compliance, and improve manufacturing efficiency. This position owns the end-to-end MES change management process for assigned manufacturing processes, from initiation and impact assessment through testing, implementation, and closure. It also supports validation activities, deviation resolution, troubleshooting, site initiatives, audit readiness, and closure of regulatory findings. The role is a long-term contract with the possibility of extension, based in Hillsboro, Oregon. Pay is $70 per hour on W2, depending on experience.

Requirements

Bachelor’s degree in a relevant field with 3–5 years of experience in MES, Electronic Batch Records (EBR), or computerized systems in regulated manufacturing, or a relevant master’s degree.
Hands-on experience with the construction, testing, and validation of computerized systems.
Experience managing electronic change control processes using systems such as Veeva Quality or TrackWise.
Knowledge of Computerized Systems Validation (CSV), Computer Software Assurance (CSA), GAMP principles, and quality systems.
Experience developing and executing test scripts, validation protocols, test plans, and technical documentation.
Understanding of electronic data systems, data integrity, and regulatory compliance requirements.
Familiarity with manufacturing automation systems, including SAP, MES, Programmable Logic Controllers (PLCs), and Human-Machine Interfaces (HMIs).
Experience working in a regulated pharmaceutical or biotechnology manufacturing environment.
Demonstrated ability to manage change requests, coordinate cross-functional action items, and drive changes through implementation and closure.
Strong troubleshooting, analytical, documentation, communication, and project coordination skills.

Nice To Haves

Experience in sterile pharmaceutical manufacturing, including solution preparation, equipment preparation, formulation, vial filling, lyophilization, prefilled syringes (PFS), inspection, or packaging.
Experience troubleshooting Rockwell Automation systems, including remote or on-site support.
Prior involvement in MES or Electronic Batch Record (EBR) deployment projects.
Experience supporting manufacturing technology transfers, capital projects, and new product launches.
Experience investigating complex MES defects, deviations, and corrective and preventive actions (CAPA).

Responsibilities

Lead requirements gathering and initial assessments for MES modifications based on manufacturing and operational needs.
Translate operational requirements into MES recipe and workflow specifications.
Develop, author, and execute Computerized Systems Validation (CSV) protocols, including Configuration Verification (CV) and Functional Verification (FV) testing.
Create and execute test scripts and test plans for MES changes, new recipes, and workflow modifications.
Investigate and assess exceptions and deviations identified during validation testing, ensuring appropriate resolution and documentation.
Own the end-to-end MES change management process for assigned manufacturing processes, from initiation and impact assessment through testing, implementation, and closure.
Manage MES-related deviations, including complex or multi-site issues associated with system defects, and ensure corrective actions address root causes.
Monitor project schedules, identify risks or delays, and escalate concerns to leadership in a timely manner.
Troubleshoot mechanical and automation-related production issues and identify opportunities to improve system performance, reduce costs, and increase operational efficiency through data analysis.
Support site initiatives involving capital projects, technology transfers, Drug Substance (DS) and Drug Product (DP) changes, shutdowns, and new product launches.
Collaborate with Manufacturing, P&C, IT/OT, Master Data, Quality, and other stakeholders to ensure effective implementation of MES changes.
Provide MES-related audit support, including system demonstrations, presentations, documentation, and responses to auditor questions.
Support the resolution and closure of MES-related regulatory findings, as required.