About this opportunity
Adryan lists this Senior CSV Engineer / MES Validation Lead opportunity in oregon, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
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
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Worksite address
oregon, WI, 53575, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.