MES Validation Engineer

This is a fully remote position, open to applicants in Oregon.

📋 Description

• Create, write, review, and implement validation protocols, test scripts, and validation reports for MES and computerized systems.

• Assist in the implementation and validation of Rockwell FactoryTalk PharmaSuite and associated manufacturing systems.

• Partner with IT/OT, Quality Assurance, Manufacturing, System Owners, and Business Process Owners to ensure that validation activities meet GMP standards.

• Formulate validation strategies, conduct risk assessments, create traceability matrices, and develop testing plans.

• Carry out Computer System Validation (CSV) tasks including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Acceptance Testing (UAT), and system qualification.

• Ensure adherence to FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity standards.

• Aid in change control processes, manage deviations, conduct CAPA investigations, and prepare for audits.

• Oversee testing execution, track defects, and manage validation deliverables throughout the project lifecycle.

• Engage with regulated systems such as MES, LIMS, SCADA, ERP, and electronic records systems.

• Offer technical advice on validation best practices and system compliance.

⛳️ Requirements

• Bachelor's degree in Biomedical Engineering, Computer Science, Biology, Biochemistry, Chemistry, Biotechnology, Regulatory Affairs, Information Technology, or a related Life Sciences discipline.

• At least 5 years of experience in Computer System Validation (CSV) or Validation Engineering within a GMP-regulated setting.

• Proficiency with Rockwell FactoryTalk PharmaSuite.

• Comprehensive understanding of FDA, EMA, GxP, GAMP 5, and 21 CFR Part 11 regulations.

• Proven experience in authoring and executing validation protocols and test scripts.

• Familiarity with risk assessments, change control, deviations, and CAPA processes.

• Excellent verbal and written communication skills.

• Capability to collaborate effectively in cross-functional teams.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid Sick Leave

• 401K