Senior CSV Engineer — MES Validation Lead (GMP)

Adryan B.V; Bend, Northern (OR, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Adryan is seeking a senior CSV Engineer / MES Validation Lead to independently drive CSV activities for MES and related manufacturing systems at a pharmaceutical site in Oregon. The role focuses on ownership of MES validation lifecycle from requirements through testing, release and change control.

The candidate will collaborate with Manufacturing, Automation, Engineering, IT/OT and Quality to ensure compliant validation across MES, EBR/eBR, and interfaces with ERP/LIMS/DCS/SCADA/PLC, while

Qualifications

• 7+ years CSV experience in regulated life sciences.
• Hands-on MES validation experience required.
• Experience leading MES/CSV workstreams.
• Knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11.
• Experience in GMP manufacturing environments.
• Strong communication with cross-functional stakeholders.

Responsibilities

• Lead and execute CSV activities for MES and related manufacturing systems.
• Own or lead the MES validation workstream with planning, risk assessment, documentation, testing and release.
• Develop and review Validation Plans, URS, FD/S, risk assessments, traceability matrices, IQ/OQ/PQ protocols, and validation reports.
• Support MES implementation, configuration, upgrade and lifecycle management.
• Translate manufacturing processes and GMP requirements into MES validation requirements.
• Apply risk-based validation per CSA and follow GAMP 5.
• Ensure compliance with 21 CFR Part 11 and EU GMP Annex 11.
• Coordinate across Manufacturing, Automation, IT/OT, Engineering and Quality to milestones.
• Support deviations, investigations, CAPAs, troubleshooting and inspection readiness.
• Validate interfaces between MES and ERP, LIMS, DCS, SCADA, PLC.

Skills

CSV validation

MES validation

GAMP 5

21 CFR Part 11

Data Integrity

Change control

Documentation

Stakeholder mgmt

Tools

Werum PAS-X

Rockwell PharmaSuite

Siemens Opcenter

Job description

Adryan is seeking a senior CSV Engineer / MES Validation Lead to independently drive CSV activities for MES and related manufacturing systems at a pharmaceutical site in Oregon. The role focuses on ownership of MES validation lifecycle from requirements through testing, release and change control.

The candidate will collaborate with Manufacturing, Automation, Engineering, IT/OT and Quality to ensure compliant validation across MES, EBR/eBR, and interfaces with ERP/LIMS/DCS/SCADA/PLC, while