Find work in the United States.

6,076,441 jobs across our US network. How we count

Jobs in the United States

25+ jobs

Save this search

Added just now
Lead Structural Engineer 1 - Grid
Sargent & Lundy
Chicago, IL
You will perform structural analysis and detailed design of steel frames, connections, concrete members, equipment, and foundations.
Added just now
Lead Structural Engineer 1 - Energy & Industrial Group
Sargent & Lundy
Englewood, CO
Using our state-of-the-art computer tools, you will perform structural analysis and design of steel frames, connections, concrete members, equipment and piping supports, and foundations.
Added 2 mins ago
Senior R&D Mechanical Engineer
DePuy Synthes Products Inc. Legal Entity
Boston, MA
We are searching for the best talent for a Senior R&D Mechanical Engineer to join our Orthopaedics team. This is a hybrid position that will be based in Boston, MA.
Added 4 mins ago
Regulatory Engineer
Northwood Space
Los Angeles, CA, CA · Washington D.C.
Northwood is hiring a Regulatory Engineer to help license our global ground station network. Working directly with our RF Regulatory Licensing Manager, you will prepare and file earth…
Added 4 mins ago
Incoming Quality Technician
Northwood Space
Los Angeles, CA, CA
- Hands-on proficiency with precision measurement and inspection equipment, including handheld tools, CMMs, optical inspection systems, and custom fixtures, plus experience managing…
Added 5 mins ago
Engineer, Energy, Sweeny Refinery
Phillips 66
Sweeny, TX
As an Engineer, Energy, you’ll help improve the refinery’s energy performance, reliability, and emissions profile. You’ll analyze energy use across heaters, boilers, heat exchangers, and…
Added 6 mins ago
Senior Data Integration Engineer
Everon
Irving, TX
The Senior Data Integration Engineer designs, develops, implements, and supports secure, scalable, and reliable integrations across enterprise applications, databases, cloud platforms,…
Added 7 mins ago
Senior Solutions Engineer-ERP (term-limited)
Seattle, WA
The Senior Solutions Engineer is responsible for determining requirements, designing, developing, debugging, testing, implementing, maintaining, administering, monitoring and supporting…
Added 7 mins ago
Quality Supervisor
Precoat Metals
Greenfield, IN
…coating technologies, developing unique coatings, ink and film systems, and designing multifaceted prints while reducing the cycle time to market. We are able to achieve this "culture of…
Added 13 mins ago
Launch and Test Engineer III (Avionics)
Blue Origin Personnel, LLC
Space Coast, FL
We are seeking a hands-on, detail-oriented Launch & Test Engineer to join our OLS Test Operations team within the Launch Site Execution (LSE) branch of the Launch Operations Division at…
Added 13 mins ago
Test Engineer II | Launch Ops (Mechanical/Fluids)
Blue Origin Personnel, LLC
Space Coast, FL
We are seeking a hands-on, detail-oriented Test and Launch Engineer to join our Launch Operations team at Blue Origin. As a part of a small, passionate, and accomplished team of experts,…
Added 13 mins ago
MK1 Engineer - Fluid Systems II
Blue Origin Personnel, LLC
Space Coast, FL
…to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the…
Added 13 mins ago
Structural Engineer - Steel Structures (Level II & III)
Blue Origin Personnel, LLC
Space Coast, FL
As part of a hardworking team of engineers, you will work on designing and developing key structural ground systems for Blue Origin’s launch site at LC-36 (Cape Canaveral, FL). You’ll have…
Added 13 mins ago
SDE III for Manufacturing Systems
Blue Origin Personnel, LLC
United States
…to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the…
Added 13 mins ago
Fluids Test Engineer III - Lunar Permanence
Blue Origin Personnel, LLC
Space Coast, FL
…to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the…
Added 13 mins ago
Avionics Subsystems, Aerospace Systems Engineer 3
Blue Origin Personnel, LLC
Space Coast, FL · Denver, CO
…to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the…
Added 13 mins ago
Quality Engineer II
Blue Origin Personnel, LLC
United States
…to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the…
Added 16 mins ago
Application Engineer
Actalent
Seymour, CT
Job DescriptionThis hands-on Application/Process Engineer role focuses on developing PCB rework and repair solutions in close collaboration with customers. You will demonstrate advanced…
Added 16 mins ago
Cad Drafter
Actalent
Bedminster, NJ
Develop CAD drawings from engineer markups, field measurements, photographs, sketches, existing drawings, and survey information.
Added 16 mins ago
A
Traveling Surveyor
Actalent
El Paso, TX
- $40 USD / hour
Experience working with electrical infrastructure, substations, medium-voltage systems, or underground utilities.
Added 16 mins ago
Mechanical Engineer
Actalent
Rockford, IL
Job Title: Mechanical EngineerJob DescriptionResponsible for the design, development, and implementation of industrial equipment, machinery safety systems, and fuel train assemblies used in…
Added 18 mins ago
Senior Systems Administrator
NFI Industries
CAMDEN, NJ · EASTVALE, CA
As a member of the Infrastructure & Operations team, the Senior Systems Administrator provides lifecycle management of infrastructure services including planning, engineering, and support.…
Added 22 mins ago
Senior R&D Mechanical Engineer
DePuy Synthes Products Inc. Legal Entity
Boston, MA
We are searching for the best talent for a Senior R&D Mechanical Engineer to join our Orthopaedics team. This is a hybrid position that will be based in Boston, MA.
Added 22 mins ago
RU
Electrical Engineer
Randstad USA
Florence, SC
- $43 to $47.79 USD / hour
AutoCAD,ECAD,embedded software,control applications,PSpice,system analysis,systems analysis,Zuken,analytical,written and verbal communications skills,logical reasoning,Good interpersonal…
Added 24 mins ago
Mechanical Product Design Engineer II
Daimler Truck North America LLC
Portland, OR
Designs and develops mechanical products, components, or systems including applying mechanical engineering principles to develop products, components, and systems that involve movement…

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