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Senior Computer System Validation Csv Jobs in Oregon

Natera

Comp. Sys Validation Spec

OR · On-site +1

... computer system validation projects * Draft IQ/OQ/PQ software plans, protocols, and reports * Ensure validation state of software systems are maintained * Act as subject matter expert for CSV ...

Genentech

Senior Quality Assurance Engineer

Hillsboro, OR · On-site

$93 - $172.80/hr

The Opportunity Senior Quality Assurance Engineer , you will provide day‑to‑day Quality ... Computer System Validation (CSV). * Approve Critical Validation: Review and approve essential ...

Genentech

Senior Quality Assurance Engineer

Hillsboro, OR · On-site

$93K - $172K/yr

The Opportunity As a Senior Quality Assurance Engineer , you will provide day-to-day Quality ... Computer System Validation (CSV). * Approve Critical Validation: Review and approve essential ...

Genentech

Senior Quality Assurance Engineer

Hillsboro, OR · On-site

$93K - $172K/yr

The Opportunity As a Senior Quality Assurance Engineer , you will provide day-to-day Quality ... Computer System Validation (CSV). * Approve Critical Validation: Review and approve essential ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR

Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ... While performing the duties of this job, the employee is regularly required to use a computer ...

ASK Consulting

Be Seen First

CSV/CQV Validation Specialist (cur_1_129769@curatelyai.net)

Bend, OR · On-site

$93/hr

CSV/CQV Validation Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Pay rate ... System Retirement Documentation * Support qualification and validation activities for new and ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ... While performing the duties of this job, the employee is regularly required to use a computer ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ... While performing the duties of this job, the employee is regularly required to use a computer ...

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Senior Computer System Validation Csv information

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the most commonly searched types of Computer System Validation Csv jobs in Oregon?

The most popular types of Computer System Validation Csv jobs in Oregon are:

What are popular job titles related to Senior Computer System Validation Csv jobs in Oregon?

For Senior Computer System Validation Csv jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Senior Computer System Validation Csv jobs in Oregon look for?

The top searched job categories for Senior Computer System Validation Csv jobs in Oregon are:

What cities in Oregon are hiring for Senior Computer System Validation Csv jobs?

Cities in Oregon with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Oregon as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 16% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% 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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