Senior CSV Engineer / MES Validation Lead

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

The Opportunity

Adryan is looking for an experienced Senior Computer System Validation (CSV) Engineer / MES Validation Lead to support a pharmaceutical manufacturing site in Oregon. The successful candidate will take ownership of CSV activities with a strong focus on MES and related manufacturing systems, working closely with Manufacturing, Automation, Engineering, IT/OT and Quality.

Ideally someone who understands how an MES operates in a pharmaceutical manufacturing environment, can translate manufacturing processes into validated system requirements, and can drive the MES validation lifecycle from requirements through testing, release and change control.

Key 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.

Required Experience

• 7+ years of CSV experience in pharmaceutical, biotechnology or another regulated life-sciences environment.


• Strong, demonstrable hands‑on MES validation experience is essential.


• Experience leading or independently owning an MES/CSV workstream.


• Strong knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, Data Integrity and risk-based validation.


• Experience across the full computerized system lifecycle: requirements, design review, testing, qualification, release, change control and periodic review.


• Experience working directly within a GMP manufacturing environment.


• Ability to communicate effectively with Manufacturing, Automation, IT/OT, Engineering and QA stakeholders.


• Strong documentation, troubleshooting and stakeholder‑management skills.


• Ability to work independently and deliver in a fast‑paced project environment.

Highly Preferred

• Experience with Werum / Körber PAS-X, Rockwell PharmaSuite, Siemens Opcenter or another enterprise MES platform.


• MES integration with ERP, LIMS, DCS, SCADA, PLC or historian systems.


• Electronic Batch Records (EBR/eBR), recipe management and master batch record configuration.


• MES equipment integration, automation interfaces, data migration and system interfaces.


• CSA / risk-based assurance approaches and validation of manufacturing automation systems.


• Experience in Oral Solid Dosage, drug product, small‑molecule manufacturing, spray drying or related pharmaceutical operations.


• Experience in greenfield, expansion or major system implementation projects.

About Adryan

Adryan is an international engineering and quality consultancy dedicated to the pharmaceutical and biotechnology industry. We support leading life-sciences organizations across Europe and the United States with specialized expertise in Commissioning & Qualification, Computer System Validation, Quality & Compliance, Engineering and Project Management.

For this assignment we are looking for a senior professional who can make an immediate impact, strengthen our delivery in Oregon and become an important part of our growing US project organization.

united-states