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Added 2 mins ago
A
Quality Engineer II
Actalent
Cudahy, WI
- $45 to $60 USD / hour
Job Description: Quality Engineer IIThis Quality Engineer II role focuses on driving robust quality processes within a fast-growing manufacturing environment that produces switchgear,…
Added 2 mins ago
A
Mechanical Engineer
Actalent
Morris, IL
- $100,000 to $120,000 USD / year
Utilize 3D scanning, reverse engineering, and 3D printing for design validation.
Added 3 mins ago
Mechanical Engineer- Precision Mechanical Design
MicroVision
Orlando, FL
…lidar-based perception solutions for industrial, security & defense, and automotive markets and delivering integrated hardware and software solutions designed for real-world performance,…
Added 3 mins ago
O
Principal Core Infrastructure Engineer
Oracle
Nashville, TN
- $114,600 to $234,600 USD / year
Leads development and begins architecting components of scalable, elastic distributed systems. Defines and enforces scalability requirements for owned components; optimizes code and data…
Added 4 mins ago
Principal Electro-Optical Integration & Test Engineer
RTX
United States
The Effectors Optics Department is seeking a Principal Electro-Optical Integration & Test Engineer to join a multidisciplinary team supporting development, qualification, and production of…
Added 4 mins ago
Program Supplier Quality Engineer - 50% travel
RTX
Remote, United States
Participate in design reviews, process change reviews, qualification test reviews, and test equipment validation.
Added 4 mins ago
Senior Systems Engineer - MANTA SEIT (Onsite)
RTX
United States
Join our MANTA SEIT Department as a Senior Systems Engineer, where you will play a critical role in supporting the development, integration, and validation of resilient navigation systems.…
Added 4 mins ago
Senior Systems Engineer, Network Architecture & Infrastructure Protection (Onsite)
RTX
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As a Senior Systems Engineer within Strategic Defense Solutions (SDS), you will apply your technical expertise to the development of advanced Strategic Nuclear Deterrence capabilities,…
Added 4 mins ago
Deputy Chief Engineer
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The Secure Subsystems Engineering team seeks a Deputy Chief Engineer. The Secure Subsystems Department is responsible for the design, test, and certification of cross-domain technologies…
Added 7 mins ago
Sr Systems Engineer
Rite-Hite Doors, Inc.
Dubuque Headquarters, IA · Milwaukee, WI
Define system verification, validation, and acceptance strategies
Added 7 mins ago
Software Engineer - Aircraft Surveillance Systems
Real Time Consulting, LLC
Phoenix, AZ
Ability to quickly come up the learning curve and determine how to set up the test environment (Validation Facility)
Added 8 mins ago
Autonomy Engineer - Millennium Space Systems
Millennium Space Systems
El Segundo, CA
As an Autonomy Engineer you will support Autonomy for a program, study, or proposal. You will evaluate fault & autonomy requirements; define states, modes, and transitions; support…
Added 8 mins ago
KC-46A Mission Systems Avionics Engineer (Mid-Level, Lead or Senior)
The Boeing Company
Everett, WA · Tukwila, WA
…responsible for supporting engineering design, integration, test, certification, and hardware/software management for assigned mission systems avionics…
Added 8 mins ago
Senior Responsible Engineer - PAC-3 Mission IPT
The Boeing Company
Huntsville, AL
Familiarity with test equipment design and validation
Added 8 mins ago
Mechanical, Test & Validation Engineering 2
Manpower Engineering
Atlanta, GA
Our client is seeking a Powertrain Durability Test Engineer to join their team. As a Powertrain Durability Test Engineer, you will be part of the Powertrain Engineering Department…
Added 8 mins ago
ME
Hardware Development Engineer
Manpower Engineering
Milwaukee, WI
- $40 to $50 USD / hour
Our client, a global leader in industrial automation and control technologies, is seeking a Hardware Development Engineer to join their engineering team. As a Hardware Development Engineer,…
Added 10 mins ago
Emulation Verification Engineer
Apple
CA · San Diego, CA
Preparing and executing the test plan and performing reviews with the cross functional teams
Added 10 mins ago
Emulation Verification Engineer
Apple
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Preparing and executing the test plan and performing reviews with the cross functional teams
Added 13 mins ago
Sr Embedded Software Engineer - Flight Mgmt Systems (FMS)
Aerospace
Phoenix, AZ
Perform software integration, validation, and troubleshooting on hardware test benches.
Added 17 mins ago
Senior Systems Engineer-Development
BAE Systems
Nashua, NH
Experience aiding in the development and production of a complex electro/mechanical system including requirements development, integration, test, verification & validation and qualification
Added 17 mins ago
Data Scientist II
BAE Systems
Rockville, MD
- Partner with software engineer, test engineers, test manager, and other stakeholders to translate business needs into technical data solutions
Added 17 mins ago
Core Repairs Engineer
GE Vernova International LLC
United States
The Core Repair team is responsible for the creation of methods, processes and tools that are utilized for unplanned maintenance such as Major Component Upgrades and Uptower Repairs to…
Added 17 mins ago
Back Office Support Engineer
GE Grid Solutions, LLC
United States
GE Vernova is seeking a skilled Back Office Support Engineer to provide remote technical, engineering, and operational support for field commissioning, testing, and startup activities of…
Added 24 mins ago
Senior Software Engineer - Lab Automation
Genentech, Inc.
United States
and accelerate decision-making. As a software engineer, you will bridge the gap between scientific workflows and modern software solutions, which may include working alongside laboratory…
Added 27 mins ago
Senior Test Infrastructure & Reliability Engineer, Photonics
PsiQuantum
Palo Alto, CA
As an integral part of the team developing a photonic quantum computer, the Senior Test Infrastructure & Reliability Engineer will own the data pipeline and reliability of the systems that…

Watchmaker Genomics

Computer Systems Validation (CSV) Engineer

Boulder, CO, United States

Full-time

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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.

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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

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