Find work in the United States.

A simpler way to find your next job.

Jobs in the United States

25+ jobs

Save this search

Added just now
Senior Cloud Platform Engineer, Code Quality Platforms
Fidelity Technology Group, LLC
Westlake, TX
As a Senior Cloud Engineer on the Code Quality Platform team, you will design, build, and maintain platforms and tools that help engineering teams improve software quality, accelerate…
Added just now
Senior Network Engineer
Fidelity Technology Group, LLC
Westlake, TX
Serve as a senior technical troubleshooter for complex, high-severity production incidents affecting Fidelity associates, applications, and external customers.
Added 2 mins ago
Forward Deployed Engineer
Enlighten AI Labs
Atlanta, GA
Reproduce and diagnose issues across APIs, datasets, and applications. Share what you've verified and propose a fix.
Added 3 mins ago
Intermediate Process Automation & Controls Engineer
Worley
Metairie, LA · Metairie
We are seeking an Intermediate Process Automation & Controls Engineer to join our Consulting team in Metairie, Louisiana. This position is ideal for an engineer with 3-8 years of experience…
Added 3 mins ago
Junior Process Engineer
Worley
ON, CA
We are currently recruiting for a Junior Process Engineer. Our team includes world class experts and dynamic go-getters. This is a full-time position based in Sarnia, Ontario.
Added 3 mins ago
Senior Process Automation & Controls Engineer
Worley
Metairie, LA · Metairie
We are seeking a Senior Process Automation & Controls Engineer to join our Consulting team, the office location is in Metairie, Lousina. This position is ideal for an experienced engineer…
Added 3 mins ago
SE
Lead Power Electronics Engineer - Solid-State Circuit Breakers
Schweitzer Engineering Laboratories, Inc.
WA
- $107,600 to $161,500 USD / year
Experience with gate drive design and high-speed switching applications.
Added 6 mins ago
A
Building Engineer
Aerotek
BELLEVUE, WA
- $90,000 to $93,600 USD / year
…well-established property management team as a Building Maintenance Engineer supporting commercial properties in Bellevue. This hands-on role is ideal for someone with experience in HVAC,…
Added 7 mins ago
Digital Technology Specialist - Data and Analytics
Bently Nevada, LLC
United States
This Senior AI/ML Engineer role is part of the Data, Analytics & AI team, responsible for developing innovative data-driven products and artificial intelligence solutions that power the…
Added 9 mins ago
Field Clinical Engineer/Clinical Sales Support
Kardion
Phoenix, AZ
…our global operating model, we are seeking a Field Clinical Engineer / Clinical Sales Support professional to work directly with physicians and catheterization lab staff to produce…
Added 9 mins ago
K
Field Clinical Engineer/Clinical Sales Support
Kardion
New York, NY
- $140,000 to $160,000 USD / year
…our global operating model, we are seeking a Field Clinical Engineer / Clinical Sales Support professional to work directly with physicians and catheterization lab staff to produce…
Added 10 mins ago
TT
Member of Technical Staff, Senior
True Talent Solutions Partners
New York, NY
- $150,000 to $300,000 USD / year
- Five to fifteen years of experience building products from zero to one as a full-stack engineer.
Added 10 mins ago
NB
Senior Software Engineer
Nelnet Business Solutions
Madison, WI · Centennial, CO
- $120,000 to $150,000 USD / year
As a Senior Software Engineer at FACTS SIS, you will be a key component of the application development process. You will work closely with Product, Engineering and other internal teams to…
Added 10 mins ago
TT
Founding Product Engineer
True Talent Solutions Partners
San Francisco, CA
- $165,000 to $210,000 USD / year
- Experience delivering applied product engineering, including LLM-powered applications or coding agents.
Added 11 mins ago
Senior Full Stack Software Engineer - Identity Verification & Proofing
Intuit
San Diego, CA · Mountain View, CA
Come join the join Intuit’s Identity Verification Team as a Senior Software Engineer. You’ll be part of a team developing highly available, scalable, industry leading services and…
Added 11 mins ago
Sr. Staff Software Engineer
Intuit
Mountain View, CA
Join the QuickBooks AI PD team as a Sr. Staff Software Engineer and be at the forefront of revolutionizing financial management through AI-driven experiences. At Intuit, we're dedicated to…
Added 13 mins ago
Staff Engineer
BlackLine Systems, Inc.
United States
As a Staff Software Engineer, you will play a crucial role in building the next generation of BlackLine and data platform. BlackLine thrives on data and we are investing heavily in being…
Added 15 mins ago
Cyber Security Engineer
Academy Sports + Outdoors
Katy, TX
Your work focuses on protecting enterprise systems, applications, identities, networks, and cloud environments through practical security controls and ongoing analysis. You administer data…
Added 16 mins ago
A
Senior AI Engineer
Arine
Remote, United States
- $170,000 to $190,000 USD / year
…adherence, and optimize interventions at scale. As a Senior AI Engineer, you will play a key role in designing, building, and deploying AI-powered solutions that enhance clinician…
Added 17 mins ago
National Manager, Software Engineer
Toyota
Plano, TX
The ideal candidate for this role will have a strong technical expertise in full stack engineering, operational excellence, applications security and public cloud technologies
Added 19 mins ago
Senior Associate, Systems Engineer - Spacecraft Operator
L3Harris Technologies
Palm Bay, FL
Job Title: Senior Associate, Systems Engineer – Spacecraft Operator
Added 19 mins ago
Senior Specialist, Systems Engineer - Mission Planner
L3Harris Technologies
Palm Bay, FL
Job Title: Senior Specialist, Systems Engineer – Mission Planner
Added 20 mins ago
Senior Principal Software Application Security
The Huntington National Bank
Remote, United States
AI Solution Development: Design, build, and deploy AI/ML and generative AI applications to support cybersecurity operations and enterprise use cases.
Added 22 mins ago
EW
Mechanical & HVAC Refrigeration Intern (Summer 2027)
EMC Water LLC
Downers Grove, IL
- $20 to $25 USD / hour
Evaluate new components, technologies, and design concepts for future product applications.
Added 22 mins ago
BT
Field Application Engineer, AI Cloud
Bitdeer Technologies Group
San Jose, CA
- $140,000 to $180,000 USD / year
We are seeking an experienced Field Application Engineer to lead technical due diligence on data centers for AI and GPU infrastructure deployment. This role is responsible for assessing…

Watchmaker Genomics

Computer Systems Validation (CSV) Engineer

Boulder, CO, United States

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Posting language: English
Posted: Nov 3, 2026

Original job description

Position: Computer Systems Validation (CSV) Engineer

Position Type: Full-time, permanent

Department: Information Technology (IT)

Location: Boulder, onsite

Experience: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline and 5+ years CSV experience in a GxP-regulated environment. Will consider those without a Bachelors with commensurate experience (AS+7 years or no degree+9 years).

Position Summary

Watchmaker Genomics is inviting applications for the full-time Computer Systems Validation (CSV) Engineer position, an on-site role in Boulder, Colorado. This position reports to the Director of IT, Boulder, and is responsible for leading the end-to-end validation of computerized systems within the environment. This position will perform day-to-day tasks related to the design, creation, and execution of validation protocols, test scripts, change management, and end-user training activities.

Additionally, this position is expected to assist in creating new processes, ISO 13485:2016, GxP, and 21 CFR Part 11-related documentation to support and maintain the organization's computer systems validation efforts. This may include, but not be limited to, plans, URS documentation, assessments, and summary reports.

The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and compliance posture. This position will offer unique challenges, learning, and growth in a cutting-edge genomics and life sciences environment.

Responsibilities

Core Responsibilities

Validation Lifecycle & Delivery

Lead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.
Manage the full lifecycle of assigned systems, including laboratory, manufacturing, and cloud-based applications.
Compile validation summary reports and secure required approvals for systems entering operational use.
Apply risk-based validation methodology to scope effort proportionate to system risk and complexity.

Cross-Functional Collaboration

Collaborate with IT, QA, Product Development, Operations, and R&D stakeholders to gather requirements, support implementation, and ensure validation readiness.
Translate operational, laboratory, and manufacturing needs into validation strategy and deliverables.
Partner with IT Directors (and future CSV Manager and Principal CSV Engineer) to align local execution with the validation framework and programme priorities.

Technical Leadership & Mentoring

Mentor junior CSV team members and provide technical guidance on CSV best practices.
Contribute to internal CSV capability uplift through knowledge sharing and review feedback.
Support recruitment and onboarding activities for new CSV team members as requested.

Technical Operations & Validation

Risk-Based Validation

Perform risk assessments using approved methodology and apply a risk-based approach to all CSV activities.
Document risk decisions and validation rationale to provide defensible audit evidence.
Apply risk-based testing strategies across IQ, OQ, and PQ activities.

Change Control & Periodic Review

Manage and document change controls for validated systems, ensuring all changes are assessed, approved, and implemented in line with regulatory and Quality Management System (QMS) requirements.
Conduct periodic reviews of validated systems to confirm continued compliance and fitness for purpose.
Update validation documentation following approved changes to assigned systems.

Incident Response & Deviation Management

Lead CSV response activities during system incidents or unplanned changes affecting validated environments.
Identify, document, and manage deviations, CAPAs, and change controls related to validated systems.
Coordinate remediation actions with IT, QA, and business stakeholders, and communicate status throughout.

Cloud-Based System Validation

Validate and monitor cloud-based GxP applications in line with regulatory expectations.
Review cloud system configurations and access controls regularly to maintain a validated state.
Partner with IT on cloud infrastructure changes that may impact validated environments.

SOPs & Validation Documentation

Author and review CSV SOPs, work instructions, and standard templates.
Maintain validation documentation and traceability across requirements, tests, and evidence.
Ensure documentation meets QMS and regulatory expectations for audit readiness.

Compliance, Risk & Quality Assurance

Regulatory Compliance & Data Integrity

Ensure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs.
Monitor validated systems for data integrity adherence, escalate, and remediate issues with QA.
Maintain alignment with ISO 13485 for in-scope systems and support QMS-driven activities.

Audit & Inspection Support

Serve as CSV subject matter expert during internal audits and external regulatory inspections for assigned systems.
Prepare inspection-ready validation evidence and respond to findings through CAPA.
Provide a defensible regulatory rationale for validation decisions and approach.

Regulatory Intelligence Application

Monitor changes in regulatory requirements and industry guidance and assess their impact on validated systems.
Apply emerging best practice and guidance to ongoing validation activities.

Skills and Requirements

Minimum 5 years of experience in CSV within a regulated environment (biotech, pharma, or medical devices);
Proven experience authoring and executing IQ/OQ/PQ protocols for a range of system types;
Strong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles;
Demonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously;
Experience supporting internal and external regulatory audits and inspections as a CSV subject matter expert;
Experience authoring and reviewing CSV SOPs, work instructions, and validation templates;
Strong interpersonal skills and an ability to work as an effective member of a team;
Proven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.

Preferred Additional Experience:

Experience in multi-national or corporate environments is essential;
Experience with CSV for laboratory equipment qualification and computerized laboratory systems;
Familiarity with IT infrastructure in a GxP context, including IQ/OQ of servers, networks, and virtualized environments;
Experience with CSV for cloud-based SaaS applications in regulated environments;
Familiarity with industry standards and regulations such as ISO, POPIA, GDPR, or HIPAA as they apply to data integrity and systems compliance;

Education and Experience

Bachelor’s degree in Computer Science, Engineering, or a related field, with a minimum of 5 years’ CSV experience in a GxP-regulated environment, or
7+ years of relevant CSV experience in a GxP-regulated biotech or pharmaceutical environment, without a formal degree requirement, provided the candidate can demonstrate equivalent knowledge and competency.

Environmental Conditions: Successful candidate(s) may need to manage multiple validation projects simultaneously and may be required to reprioritize based on audit schedules, system implementation timelines, or regulatory requirements. The environment is dynamic and fast-paced, requiring excellent organizational and time management skills.

Mental Demands: Successful candidate(s) will work in a compliance-critical environment where accuracy, rigor, and sound regulatory judgment are essential. The role requires maintaining high standards of documentation quality under time pressure and making well-reasoned decisions on complex validation matters.

Compensation

The budgeted range for this position starts at $120,000 - $130,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, employer covers 75% of base medical plan with buy-up options, EAP (employee assistance program), employer paid dental with a buy-up option, employer paid vision, employer paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) retirement plan with a 4% match.

Application Requirements

To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:

Letter of motivation (upload where it says cover letter)
Resume or Curriculum vitae, highlighting relevant qualifications and experience

Applications without a Letter of Motivation will not be considered. Local candidates preferred.

Applications will be accepted on a rolling basis and the position will remain open until filled; however, early submission is encouraged as review will begin immediately.

If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.

*** WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.

All applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States.

This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.

Apply About employer

More about this job

Skills

Computer science
Change management
Documentation
Regulatory compliance
SAP IQ
Collaboration
Leadership
Coaching
Recruitment
Onboarding
Quality assurance procedures
Incident response
Quality assurance
Inspection
Internal auditing
Medical devices
Interpersonal skills
Laboratory equipment
Time management

Report this job