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Computer System Validation Csv Remote Jobs in Oregon

Symbotic

Senior CAD Designer

OR · Remote

$27 - $37.25/hr

What we do The System Layout Engineering team is part of the Manufacturing and Supply Chain ... Review,validate, and approve drawings created by junior designers to ensure accuracy ...

NV5

Remote Sensing Technician

RST's configure and monitor sensor systems, track acquisition progress, download/process/ship ... A valid driver's license * Field experience * Experience with GNSS survey practices and ...

Dynamic Solutions Technology LLC

JIRA Engineer

OR · On-site +1

$49.50 - $64.75/hr

This is a REMOTE position. Duties and Responsibilities: * Assess the current Jira Data Center setup ... Conduct test migrations and validate results before production rollout. * Migrate projects ...

EnableComp

DRG Validator/Reviewer (REMOTE)

OR · Remote

Certified Coding Specialist (CCS) certification required. * 2-3 years' experience in DRG validation ... systems. * Must have strong computer proficiency and understand how to use basic office ...

David Evans & Associates Inc

CAD Technician

Salem, OR · On-site +1

$28 - $41/hr

... Remote possible.) We're looking for a skilled CAD Technician who thrives in a collaborative ... Collaborate through file-sharing systems like ProjectWise and participate in quality assurance ...

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Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

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

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
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 Computer System Validation Csv Remote jobs in Oregon? For Computer System Validation Csv Remote jobs in Oregon, the most frequently searched job titles are:
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Computer System Validation Csv Remote jobs near you

Manager/Sr. Manager - Digital Center of Excellence

Mineralys Therapeutics

OR • Remote

$140K - $175K/yr

Other

Medical, Dental, Vision, Retirement

Posted 16 days ago

Job description

"Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone.  Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.  Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky"

Mineralys is a fully remote company.

Digital Center of Excellence Project Manager

The Manager/Sr. Manager - Digital Center of Excellence is responsible for leading the planning and delivery of enterprise systems implementation projects across Mineralys, from initiation through deployment and operational transition. This role owns endtoend project execution across the System Development Lifecycle (SDLC), coordinating crossfunctional teams, vendors, and stakeholders to ensure systems are delivered on time, within scope, compliant with regulatory expectations, and ready for adoption.

Operating within a regulated life sciences environment, the Manager/Sr. Manager ensures projects align with IT governance, architecture, cybersecurity, data integrity, and electronic records requirements while supporting business objectives and inspection readiness.

Key Responsibilities

EndtoEnd IT Project Delivery

  • Lead systems implementation projects across the full SDLC, including requirements definition, solution design, configuration, integration, testing, deployment, and transition to operations.
  • Develop and maintain integrated project plans, timelines, risks, and dependencies to support successful delivery and golive readiness.
  • Own execution quality, issue resolution, and progress tracking to ensure predictable, wellmanaged outcomes.

CrossFunctional & Vendor Leadership

  • Manage crossfunctional project teams spanning IT, Quality, business functions, and external vendors.
  • Partner closely with business and system owners to translate operational needs into clear system requirements and implementation plans.
  • Coordinate vendor delivery, ensuring alignment to scope, schedule, quality expectations, and Mineralys standards.

Compliance, Validation & Inspection Readiness

  • Ensure system implementations comply with applicable regulatory, data integrity, and electronic records requirements (e.g., GxP, SOX, 21 CFR Part 11), where applicable.
  • Coordinate Computer System Validation (CSV), SOX, or other compliance activities in partnership with system owners, business owners, and Quality.
  • Maintain appropriate project and system documentation to support audits and inspections.

IT Governance & Enterprise Standards

  • Ensure projects align with established IT governance, architectural principles, cybersecurity requirements, and data management standards.
  • Support user adoption, training readiness, and operational handoff to ensure systems deliver sustained business value.
  • Contribute to the development and continuous improvement of IT project delivery practices, tools, and frameworks across the enterprise.

Skills and Attributes

  • Strong enterprise IT project leadership with the ability to operate effectively in a matrixed, crossfunctional environment.
  • Structured, disciplined approach to planning, execution, risk management, and delivery.
  • Ability to translate complex technical and regulatory requirements into clear execution plans.
  • Strong communication and stakeholder management skills, including comfort engaging with senior leaders.
  • Detailoriented, with a focus on quality, compliance, and inspection readiness.
  • Adaptive and pragmatic, able to operate effectively in fastpaced, evolving environments.

Qualifications

  • Bachelor's degree required; advanced degree preferred.
  • Minimum of 3-5 years of IT project management experience, including enterprise software or SaaS implementations.
  • 3+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated life sciences environments.
  • Demonstrated experience delivering systems subject to GxP, SOX, 21 CFR Part 11, or similar regulatory frameworks.
  • Strong working knowledge of SDLC practices for enterprise or SaaS system implementations.

Travel

  • This position requires up to 25% travel. Frequently travel is outside the local area and overnight.

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range:  $140,000 - $175,000

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