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Senior Csv Engineer Jobs in Oregon (NOW HIRING)

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

The Sr. Validation Engineer will serve as a subject matter expert, support complex technical ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

The Sr. Validation Engineer will serve as a subject matter expert, support complex technical ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

The Sr. Validation Engineer will serve as a subject matter expert, support complex technical ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

All JobsCsv Engineer JobsSenior Csv Engineer JobsSenior Csv Engineer Jobs in Oregon

Senior Csv Engineer information

What is a senior CSV engineer?

Senior CSV Engineers are experienced professionals who specialize in Computer System Validation (CSV) within regulated industries such as pharmaceuticals, biotechnology, and medical devices. Their main responsibility is to ensure that computer systems used in these industries comply with regulatory standards and function as intended. They lead validation projects, develop validation protocols, conduct risk assessments, and work closely with IT and quality assurance teams. Senior CSV Engineers also provide guidance on regulatory requirements, troubleshoot validation issues, and help maintain audit-ready documentation.

What are the key skills and qualifications needed to thrive as a senior CSV engineer?

To excel as a Senior CSV (Computer System Validation) Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11, GAMP 5), and a relevant engineering or scientific degree. Proficiency with validation lifecycle documentation, risk management tools, and quality management systems is typically required, as are certifications like PMP or Six Sigma. Strong analytical skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These skills are essential to maintaining regulatory standards, minimizing risks, and ensuring the integrity and reliability of computerized systems in regulated industries.

What are common challenges faced by senior CSV engineers when ensuring regulatory compliance across multiple projects?

Senior CSV Engineers often encounter the challenge of managing varying compliance standards and documentation requirements across multiple projects, especially when working with global teams. Keeping up-to-date with evolving regulations (such as FDA 21 CFR Part 11 or EU Annex 11) and ensuring that validation activities are harmonized across different systems can be demanding. Strong project management skills, proactive communication with cross-functional stakeholders, and meticulous attention to detail are essential for overcoming these challenges and maintaining audit-ready documentation.

What is the difference between Senior Csv Engineer vs Data Engineer?

AspectSenior Csv EngineerData Engineer
Required CredentialsBachelor's in Computer Science, Data Science, or related field; experience with CSV processingBachelor's or higher in Computer Science, Data Engineering, or related; often includes knowledge of databases and ETL tools
Work EnvironmentData processing teams, analytics departments, data pipelines involving CSV filesData infrastructure teams, big data environments, cloud platforms, and data pipelines
Employer & Industry UsageTech companies, finance, healthcare, any industry handling large CSV datasetsTech firms, finance, e-commerce, and industries requiring large-scale data integration

The main difference is that a Senior Csv Engineer specializes in managing and optimizing CSV data workflows, while a Data Engineer has a broader role in designing and maintaining comprehensive data infrastructure, including databases, pipelines, and big data systems. Both roles require similar foundational skills but differ in scope and complexity.

What are popular job titles related to Senior Csv Engineer jobs in Oregon?

For Senior Csv Engineer jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Senior Csv Engineer jobs in Oregon look for?

The top searched job categories for Senior Csv Engineer jobs in Oregon are:

Senior Csv Engineer jobs near you
Infographic showing various Senior Csv Engineer job openings in Oregon as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution.

Senior CSV Engineer / MES Validation Lead

Adryan B.V

Bend, OR • On-site

$120 - $170/hr

Other

Posted 2 days ago

New

Job description

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.

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