Senior MES Validation Lead & CSV Expert

Adryan; Oregon (WI); On-site; USD 120,000 - 150,000; Full time

Job summary

Adryan, an international engineering and quality consultancy, seeks a Senior CSV Engineer / MES Validation Lead to support a pharmaceutical manufacturing site in Oregon. You will own CSV activities focused on MES and related systems, collaborating with Manufacturing, Automation, Engineering, IT/OT and Quality.

You will translate manufacturing processes into validated system requirements and drive the MES validation lifecycle from requirements through testing, release and change control, applying

Qualifications

• Experience leading CSV projects in a regulated life-sciences environment.
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11 and Data Integrity.
• Ability to translate manufacturing processes into validated MES requirements.
• Experience with IQ/OQ/PQ, validation reports and traceability matrices.

Responsibilities

• Lead and execute CSV activities for MES and associated manufacturing systems.
• Own or lead the MES validation workstream, including planning, risk assessment, documentation, testing and release.
• Develop and review Validation Plans, URS, functional/design specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, test scripts and Validation Summary Reports.
• Support implementation, configuration, upgrade, expansion and lifecycle management of MES solutions.
• Translate manufacturing processes, electronic batch records and GMP requirements into MES system and validation requirements.
• Apply risk-based validation in accordance with GAMP 5 and modern CSA principles where appropriate.
• Ensure compliance with 21 CFR Part 11, EU GMP Annex 11 and Data Integrity / ALCOA+ expectations.
• Assess changes to MES and connected systems through formal change control and validation impact assessment.
• Support deviations, investigations, CAPAs, troubleshooting and inspection readiness related to computerized systems.
• Validate interfaces between MES and systems such as ERP, LIMS, DCS, SCADA, PLC.
• Coordinate effectively across Manufacturing, Automation, IT/OT, Engineering and Quality and drive validation activities to agreed milestones.

Skills

CSV validation

MES validation

GAMP 5

Documentation

Tools

PAS-X

LIMS

SCADA

DCS

Job description

Adryan, an international engineering and quality consultancy, seeks a Senior CSV Engineer / MES Validation Lead to support a pharmaceutical manufacturing site in Oregon. You will own CSV activities focused on MES and related systems, collaborating with Manufacturing, Automation, Engineering, IT/OT and Quality.

You will translate manufacturing processes into validated system requirements and drive the MES validation lifecycle from requirements through testing, release and change control, applying