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 1 min ago
IT Assurance Specialist SME
Chenega Corporation
Arlington, VA
At Cyberstar, we aim to analyze and boost human and business performance through the implementation of business process redesign and information technology (IT) modernization to include…
Added 1 min ago
GE
Metallic Test Lab & SPTC Focal
General Electric Company
Remote, United States
- $116,000 to $154,000 USD / year
Our Supplier Quality Engineer (SQE) for S-SPEC-35 (aeDMS S400) Certified Materials Test Laboratories (CMTL), will apply their demonstrated knowledge of metallic materials testing to lead…
Added 2 mins ago
Senior CyberArk PAM Engineer
The Northern Trust Company
Tempe, AZ
…Integrity. Together, they reflect the three cornerstones of business conduct which we strive to instill in our employees, whom we call partners, and to provide to our clients and the…
Added 3 mins ago
Staff Systems Safety Engineer
Twenty-Six Defense
Fort Worth, TX
…regulations and emerging safety standards. The Staff Systems Safety Engineer shapes internal and external safety policies, leads strategic industry and customer engagements, and steers…
Added 4 mins ago
Quality Engineer
Metrex Research, LLC
United States of America, WI
The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality…
Added 5 mins ago
T
Linux Messaging Engineer
TEKsystems
Irving, TX
- $60 to $65 USD / hour
NO C2C. W2 ONLY. MUST WORK ONSITE 3 DAYS A WEEK IN IRVING, TX.TEKsystems is currently looking for a Linux Messaging Engineer with SMTP/mail routing, RHEL and heavy scripting experience with…
Added 5 mins ago
T
IT Support Analyst
TEKsystems
Lansing, MI
- $25 to $30 USD / hour
We are seeking an experienced IT Support Engineer to provide advanced end-user support across a multi-site enterprise environment. This role will be responsible for troubleshooting and…
Added 5 mins ago
T
Linux Messaging Engineer
TEKsystems
Charlotte, NC
- $60 to $65 USD / hour
NO C2C. W2 ONLY. MUST WORK ONSITE 3 DAYS A WEEK IN CHARLOTTE, NC.TEKsystems is currently looking for a Linux Messaging Engineer with SMTP/mail routing, RHEL and heavy scripting experience…
Added 5 mins ago
T
Ai Engineer
TEKsystems
Palo Alto, CA
- $80 to $85 USD / hour
DescriptionSenior AI Engineer / Forward Deployed EngineerAbout the OpportunityJoin a newly formed, executive-sponsored AI Transformation organization focused on delivering enterprise-scale…
Added 5 mins ago
T
Infrastructure Engineer
TEKsystems
Foster City, CA
- $50 to $60 USD / hour
DescriptionOur client is seeking a Linux Infrastructure Operations Engineer to support critical infrastructure across on-premises, AWS, and Kubernetes (EKS) environments. This role is…
Added 7 mins ago
Staff Endpoint Engineer
SmithRx
Plano, TX
SmithRx is seeking a visionary and highly strategic Staff Endpoint Engineer to serve as the overarching technical authority and architect for our enterprise endpoint infrastructure, vendor…
Added 9 mins ago
Process Applications Engineer I-III (Semiconductor) (33546)
EBARA TECHNOLOGIES INCORPORATED
Phoenix, AZ
…everything from product definition and planning through production, process testing, and release. You will develop new or modified process formulations and must exercise judgment in…
Added 10 mins ago
Information Security Engineer
TDC Brand
Napa, CA · Sherman Oaks, CA
The Information Security Engineer protects the organization’s systems and data by owning day-to-day vulnerability management while serving as a first-tier responder for security alerts and…
Added 10 mins ago
Senior Software Engineer, AI
Anduril Industries
Costa Mesa, CA
…advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the defense industry, Anduril is changing how military…
Added 10 mins ago
Flight Test Engineer
Anduril Industries
Costa Mesa, CA
…advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the defense industry, Anduril is changing how military…
Added 10 mins ago
Sr. Equipment and Automation Engineer
Exact Sciences Corp
WI
The Senior Equipment and Automation Engineer will be responsible for leading cross-functional teams in a matrix organization to plan and successfully execute larger projects. An emphasis…
Added 10 mins ago
PPL Commissioning Engineer
CB&I
Plainfield, IL
The Principal Commissioning Engineer is an individual contributor subject matter expert within CB&I Storage Solutions for complex Commissioning, Start-up and Operations of structural and…
Added 13 mins ago
Site Reliability Engineer
E2B
San Francisco, CA
- 5+ years of production SRE, infrastructure, or platform engineering experience operating business-critical services.
Added 14 mins ago
TB
Data & Platform Engineer
Truist Bank
Richmond, VA · Atlanta, GA · Charlotte, NC
- $105,040 to $130,030 USD / year
The engineer combines strong expertise in SQL Server, Oracle, database performance tuning, data modeling, ETL/ELT development, API integration, and AWS data services to build and support…
Added 14 mins ago
TB
.Net Software Engineer
Truist Bank
Richmond, VA · Atlanta, GA · Charlotte, NC
- $105,040 to $131,300 USD / year
This Software Engineer independently designs, develops, tests, modernizes, and supports Wealth & Trust applications and integration services. The role focuses on delivering scalable,…
Added 15 mins ago
DO
Senior Safety Engineer
Department of Industrial Relations
CA
- $11,427 to $14,298 USD / month
The Senior Safety Engineer (SSE) is a working safety engineer responsible for the development of the State's occupational safety and health standards, with primary emphasis on occupational…
Added 15 mins ago
Senior Forward Deployed Engineer, AWS Forward Deployed Engineering
Amazon Web Services, Inc.
Boston, MA · Arlington, VA · Seattle, WA · New York, NY · East Palo Alto, CA
A Forward Deployed Engineer (FDE) embeds directly inside a strategic enterprise customer to design, build, deploy, and run AI-powered production systems alongside the customer's engineering…
Added 16 mins ago
Lead Research and Development Engineer
Cook Group
Bloomington, IN
…improving patients’ lives since 1963, we’re committed to doing business with integrity and making a positive impact in the communities where we live and work. We’re guided by strong ethical…
Added 16 mins ago
Scientist, DSCS Digital Technologies–Laboratory Automation, Automation Systems Engineer (Hybrid)
Merck
Rahway, NJ
…effective foundation of laboratory tools: innovative robotics, process analytical technology (PAT), high-throughput technologies, reliable instrumentation, and integrated systems that…
Added 16 mins ago
Senior Scientist, DSCS Digital Technologies–Laboratory Automation, Automation Systems Engineer (Hybrid)
Merck
Rahway, NJ
…effective foundation of laboratory tools: innovative robotics, process analytical technology (PAT), high-throughput technologies, reliable instrumentation, and integrated systems that…

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