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 1 min ago
Coordinator, Pre-Apprenticeship and Summer Bridge Programs
Forsyth Technical Community College
NC
Two years of experience in program coordination, workforce development, education, recruiting, student services, or related field.
Added 4 mins ago
CM
Director, Procurement
Centene Management Company LLC
Remote, United States
- $134,600 to $249,000 USD / year
Position Purpose: Responsible for determining the strategy for procurement governance, standards, and regulatory operations across the entire corporation. Oversee the implementation of…
Added 9 mins ago
Manager Supply Chain Programs 3
CORP-Corporate Office
United States
This manager of managers will be responsible and accountable for the strategy, planning, budget, and execution of all material and services content in support of the Radar Accelerated…
Added 9 mins ago
Manager Supply Chain Programs 3
CORP-Corporate Office
United States
Northrop Grumman is seeking a dynamic, energetic individual for the position of Supply Chain Program Manager 3 to join our growing team of diverse professionals. This Manager will be…
Added 10 mins ago
Solution Architect Manager
Allata
Remote, United States
Our teams work at the intersection of strategy, engineering, data, and design, helping clients modernize their technology, unlock data value, and create meaningful digital experiences. At…
Added 10 mins ago
Sr. Field Service Team Manager
Gatik AI
Remote, United States
…standard work instructions for vehicle retrofits. Reporting to the Director, Fleet and Maintenance Strategy, you will partner closely with local fleet managers and Techops teams across…
Added 11 mins ago
Deputy Director, Policy and Advocacy
Communities Foundation of Texas
Austin, TX
Strategy and Implementation: In collaboration with the Director of Policy and Advocacy and other Educate Texas leaders, develop and manage data-informed policy, advocacy, and implementation…
Added 13 mins ago
Senior Privacy Analyst
Upbound Field Support Center Rent A Center Texas LP
Plano, TX
…authority over risk acceptance, exceptions, escalations, and program…
Added 14 mins ago
Director, Talent and Performance Enablement
Lucchese
Dallas, TX
This is a new role and a rare chance to build an integrated talent function from the ground up. As Director, Talent and Performance Enablement, you'll own how Lucchese attracts, develops,…
Added 17 mins ago
RWE Director, Inhaled Portfolio
AstraZeneca
Wilmington, DE · Wilmington
…deliver evidence programs that close in-market gaps, inform strategy, and enable appropriate access and uptake. How would you build a payer-ready evidence plan that anticipates emerging…
Added 18 mins ago
SA
Corporate Legal Director (R6494)
Shield AI
San Mateo, CA
- $270,000 to $400,000 USD / year
Serve as a primary legal partner to Product, Engineering, Program Management, Customer Success, Information Security and Business Development across the full product lifecycle for Hivemind…
Added 18 mins ago
Vice President, Treasury
GreenSky Administrative Services LLC
Atlanta, GA · Atlanta
…a multi-disciplinary team and is comfortable moving between strategy and execution. The VP serves as a trusted advisor to the CFO and executive team, partners closely with Accounting,…
Added 18 mins ago
HG
Director Sales II
Hilton Grand Vacations
New York, NY · NY
- From $125,000 USD / year
Lead the development and execution of an annual site strategy to grow sales volume and maximize cost in line with present company objectives.
Added 20 mins ago
NE
Associate Account Director
NVE Experience Agency
NY
- $100,000 to $120,000 USD / year
We are seeking an Associate Account Director to lead integrated experiential programs and priority workstreams while serving as a client partner across key accounts. This role focuses on…
Added 20 mins ago
NE
Account Director
NVE Experience Agency
NY
- $115,000 to $140,000 USD / year
The Account Director serves as trusted advisor to client stakeholders while leading cross-functional teams across Accounts, Production, Strategy, and Creative. This individual is…
Added 21 mins ago
WM
Part-Time Director of Transitions Curriculum
WESTERN MICHIGAN UNIVERSITY SCHOOL OF MEDICINE
KALAMAZOO, MI
- Part-time
The Director, Transitions Curriculum provides unified leadership for the transition courses spanning the MD program and the graduation competency OSCE, and serves as a Clinical Coach,…
Added 21 mins ago
Senior Director Compliance, Head of Compliance Testing
First Citizens Bank
Raleigh, NC
The Senior Director, Head of Compliance Testing leads the enterprise-wide compliance testing program, providing independent oversight of regulatory compliance risks through risk-based…
Added 24 mins ago
Regional Sales Director, Small Commercial Lines (Mid-Atlantic)
The Hanover Insurance Group
Washington, DC · VA · MD
Our Small Commercial Sales department is seeking a Regional Sales Director to join our growing team in our Mid-Atlantic Region.
Added 24 mins ago
Regional Sales Director, Small Commercial Lines (Mid-Atlantic)
The Hanover Insurance Group
Washington, DC · VA · MD
Our Small Commercial Sales department is seeking a Regional Sales Director to join our growing team in our Mid-Atlantic Region.
Added 25 mins ago
Senior Ai Product Manager
GSK
Philadelphia, PA
You will set multi-year product direction, shape platform strategy alongside the Director and Principal Engineers, lead a team of PMs, and serve as the senior product voice to Director and…
Added 25 mins ago
ViiV Healthcare (GSK) Global Patient Engagement Director (US)
GSK
Durham, NC
The Global Patient Engagement Director (US) leads the development and execution of ViiV Healthcare’s patient engagement strategy across the US, ensuring that the voices, experiences and…
Added 28 mins ago
CO
Director of Financial Planning & Analysis
City of Seattle
Seattle, WA
- $66.88 to $110.35 USD / hour
Lead development of multi-year financial forecasts that support the utility’s strategic plan, capital program, rate path, and long-term financial health.
Added 29 mins ago
Director - Real World Data Scientist
Eli Lilly and Company
Remote, United States
Drives sustained integration of HEOR and use of RWD from early clinical development through commercialization.
Added 29 mins ago
Associate Director – Maintenance
Eli Lilly and Company
United States
The Associate Director – Maintenance provides leadership and direction to the maintenance organization supporting Houston API manufacturing, ensuring that maintenance deliverables are…
Added 30 mins ago
Staff Software Development Engineer
Zscaler
Santa Clara, CA
We are looking for a Staff Software Development Engineer to join our team. This is a hybrid (Santa Clara, CA) role, reporting to the Sr. Director, Software Development Engineering in the…

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