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Computer System Validation Manager Jobs in Bend, OR

Medline

Sr Engineer Software Validation

Redmond, OR · On-site

$101K - $152K/yr

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

Medline

Sr Engineer Software Validation

Redmond, OR · On-site

$101K - $152K/yr

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

Medline

Sr Engineer Software Validation

Redmond, OR · On-site

$101K - $152K/yr

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

Lonza

Instrumentation Specialist

Bend, OR · On-site

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

Lonza

Instrumentation Specialist

Bend, OR · On-site

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

Lonza

Instrumentation Specialist

Bend, OR

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

Lonza

Instrumentation Specialist

Bend, OR · On-site

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

Lonza

Instrumentation Specialist

Bend, OR

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

Serán BioScience

Senior Validation Engineer

Bend, OR · On-site

Manages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure ... Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with ...

Serán BioScience

Senior Validation Engineer

Bend, OR · On-site

Manages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure ... Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with ...

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Showing results 1-20

All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Bend, OR

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 3, 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 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 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 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:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Bend, OR as of July 2026, with employment types broken down into 56% Full Time, and 44% Contract. Highlights an 100% In-person job distribution, with an average salary of $111,213 per year, or $53.5 per hour.

Director, Quality Engineering & Computer System Assurance

Seran BioScience

Bend, OR • On-site

Full-time

PTO

Re-posted 16 days ago

Job description

Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization's validation, qualification, and computerized systems assurance programs.  This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
 
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
 
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
  • Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
  • Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
  • Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
  • Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
  • Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
Validation Lifecycle Oversight
  • Provides Quality leadership and oversight of validation programs including:
    • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
Key activities include:
  • Approval and oversight of validation lifecycle documentation including: 
    • Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
  • Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
  • Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
  • Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
Computer System Assurance (CSA) & Data Integrity
  • Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
  • Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
  • Oversees validation lifecycle management for computerized systems including:
    • Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
  • Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
  • Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
  • Supports system lifecycle activities including system upgrades, migrations, and decommissioning
Operational Quality Engineering Support
  • Provides QA oversight and approval for quality system elements impacting validated systems including:
    • Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
  • Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
  • Provides QA support for technology transfer, new product introductions, and site capital projects
  • Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
  • Supports troubleshooting of complex process or system issues impacting validated systems
  • Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
  • Leads preparation and inspection readiness programs related to validation and data integrity
Leadership & People Management
  • Leads and develops a high-performing Quality Engineering and CSA organization
  • Provides mentoring, coaching, and professional development for technical staff
  • Establish clear departmental goals aligned with organizational quality and operational objectives
  • Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
  • Fosters a culture of quality ownership, compliance, and continuous improvement
Required Knowledge and Skills
  • Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
  • Experience organizing and managing work responsibilities while working independently with minimal oversight
  • Deep expertise in Computer System Validation / Computer System Assurance
  • Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
  • Time and project management skills with the ability to multi-task and meet deadlines
  • Excellent verbal and written communication skills
  • Excellent interpersonal and customer service skills
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Strong supervisory and leadership skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Willingness to accept feedback from a variety of sources
  • Ability to constructively manage conflict
  • Ability to collaborate and work in cross-functional teams
  • Ability to function well in a high-paced and at times stressful environment
  • Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
  • Proficient with Microsoft Office Suite or related software
Education and Experience
  • Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree 
  • Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
  • Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
  • Demonstrated experience with regulatory inspections by the FDA and EU authorities
Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Adheres to consistent and predictable in-person attendance 
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
 
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
 
Benefits Summary:
Seran employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Seran covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
 
The Corporate Headquarters of Seran BioScience are located at 63047 Layton Ave, Bend, OR 97701
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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