MES Validation Engineer - (Biotech)

Nesco Resource•Hillsboro, OR

5d•Onsite

About The Position

As part of the Process and Compliance Team in manufacturing, the MES Validation Engineer performs a wide variety of tasks required to design, build, test, validate, and maintain pharmaceutical production in a highly automated production and packaging facility. The role works cross-functionally with manufacturing, P&C, ITOT, Master Data, and other departments to ensure the efficient construction and effective functionality of electronic operational documentation across HTO. The position owns CSV activities and MES change review for assigned manufacturing processes, including requirements definition, test-script development and execution, change testing, and implementation. It also supports site initiatives and audits related to MES, investigates testing exceptions and deviations, and identifies opportunities to improve system performance and operational efficiency.

Requirements

Bachelor's degree in a relevant field and 3–5 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or a master's degree in a relevant field.
Prior experience constructing, testing, and validating computerized systems.
Extensive experience with electronic change-management systems such as TrackWise or Veeva, including owning changes and coordinating action items across multiple departments.
Prior experience in IT, OT, or software technical writing, quality systems, and validation (CSV/CSA, GAMP), preferably in a regulated industry.
Strong understanding of test requirements for electronic data systems in support of regulatory compliance.
Knowledge of automation systems, including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human Machine Interfaces (HMI).
Prior experience with sterile pharmaceutical manufacturing, such as solution preparation, equipment preparation, liquid or lyophilized vial filling, prefilled syringes, formulation, inspection, or packaging.
Experience owning changes in a change-management system such as Veeva, from initiation through closure.

Nice To Haves

Experience troubleshooting Rockwell systems, including remote or onsite support, is strongly preferred.
Prior experience with an EBR or MES deployment project is preferred.

Responsibilities

Troubleshoot and identify resolutions for mechanical or automation-related production failures.
Use system-performance data analytics to identify opportunities to reduce costs and increase efficiency.
Lead user-requirement gathering for operational needs and perform initial assessments of requirements for MES modifications.
Own CSV functions, including defining requirements and writing and executing test scripts.
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 in accordance with approved procedures and CSV principles.
Investigate and assess exceptions and deviations from CV and FV protocol testing.
Plan, execute, and improve the review of MES changes for assigned manufacturing processes through change management, including testing and implementation.
Monitor project schedules and escalate concerns to leadership in time for mitigation.
Assist in drafting MES change test plans, including comprehensive test plans and/or reports for new recipes.
Own MES-related deviations, including high-complexity or multi-site deviations related to MES defects, and ensure corrective actions effectively resolve issues.
Support MES components of site initiatives, including capital projects, technology transfers, Drug Substance/Drug Product changes, shutdown projects, and new launches.
Provide MES audit support through demonstrations, presentations, and responses to questions; when applicable, support closure of MES-related regulatory findings.
Own changes in a change-management system from initiation through closure and coordinate action items across departments.