Adryan B.v

We are looking for a senior CSV professional with strong, hands-on Manufacturing Execution System (MES) validation experience who can independently lead an MES validation workstream in a GMP manufacturing environment.

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 appropriae.
• 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.