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Computer System Validation Manager Jobs in Bend, OR

Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: * 5+ ... GS1 / GUDID Management - Quality Management System / Medical device environment experience.

Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: * 5+ ... GS1 / GUDID Management - Quality Management System / Medical device environment experience.

Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: * 5+ ... GS1 / GUDID Management - Quality Management System / Medical device environment experience.

Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: 5+ years ... Management System / Medical device environment experience. Proficient in MS Word, Project, Excel.

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Experience with computerized systems validation and equipment qualification. * Experience managing multiple validation projects and competing priorities. * Previous backlog remediation or high-volume ...

Experience with computerized systems validation and equipment qualification. * Experience managing multiple validation projects and competing priorities. * Previous backlog remediation or high-volume ...

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Support computer system validation activities for lab instruments. * Create and manage validation documents, including protocols and reports. * Coordinate on-site repairs and manage vendor ...

Support computer system validation activities for lab instruments. * Create and manage validation documents, including protocols and reports. * Coordinate on-site repairs and manage vendor ...

Support computer system validation activities for lab instruments. * Create and manage validation documents, including protocols and reports. * Coordinate on-site repairs and manage vendor ...

Support computer system validation activities for lab instruments. * Create and manage validation documents, including protocols and reports. * Coordinate on-site repairs and manage vendor ...

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Showing results 1-20

Computer System Validation Manager information

See Bend, OR salary details

$50.1K

$111.2K

$169.3K

How much do computer system validation manager jobs pay per year?

As of Aug 23, 2026, the average yearly pay for computer system validation manager in Bend, OR is $111,213.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,600.00 and $139,300.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Bend, OR?

For Computer System Validation Manager jobs in Bend, OR, the most frequently searched job titles are:

Infographic showing various Computer System Validation Manager job openings in Bend, OR as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $111,213 per year, or $53.5 per hour.

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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