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Computer System Validation Manager Jobs in Colorado

Tolmar

Validation Engineer II

Windsor, CO · On-site

$90K - $100K/yr

Experience with validation software or electronic document management systems preferred. Working Conditions * Working conditions include general office environment, laboratory and manufacturing ...

Agilent

Automation Controls Engineer

Frederick, CO · On-site

$103K - $161K/yr

Support control and computer system validation activities including review and execution of automation Factory Acceptance Tests, Site Acceptance Tests, and Installation and Operational Qualification ...

Tolmar Inc.

Validation Engineer II

Windsor, CO

$90K - $100K/yr

Experience with validation software or electronic document management systems preferred. Working Conditions * Working conditions include general office environment, laboratory and manufacturing ...

Tolmar

Validation Engineer II

Windsor, CO

$90K - $100K/yr

Experience with validation software or electronic document management systems preferred. Working Conditions * Working conditions include general office environment, laboratory and manufacturing ...

GBA Companies

Validation Project Lead

Broomfield, CO

$95K - $130K/yr

Manage changes to the project scope, project schedule and project costs using appropriate ... Perform system and process risk assessments and analyses * Schedule and coordinate protocol ...

Compli

Validation Project Lead

Boulder, CO

$95K - $130K/yr

Manage changes to the project scope, project schedule and project costs using appropriate ... Perform system and process risk assessments and analyses * Schedule and coordinate protocol ...

GXM Consulting

Test & Evaluation Lead

Colorado Springs, CO · On-site

$100K - $170K/yr

... Computer Science, Information Systems, Systems Engineering, or related technical discipline. * 8+ years of experience supporting test and evaluation, systems engineering, verification and validation ...

Compli

Validation Project Lead

Broomfield, CO

$95K - $130K/yr

Manage changes to the project scope, project schedule and project costs using appropriate ... Perform system and process risk assessments and analyses * Schedule and coordinate protocol ...

Booz Allen Hamilton

Ground System Engineer

Aurora, CO · On-site +1

$99K - $225K/yr

Experience managing traceability of requirements and developing testable criteria, system validation and verification, and analysis * Experience performing systems engineering, integration, and ...

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Computer System Validation Manager information

See Colorado salary details

$49.9K

$110.8K

$168.8K

How much do computer system validation manager jobs pay per year?

As of Jul 21, 2026, the average yearly pay for computer system validation manager in Colorado is $110,846.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,300.00 and $138,800.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Colorado? For Computer System Validation Manager jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Colorado look for? The top searched job categories for Computer System Validation Manager jobs in Colorado are:
What cities in Colorado are hiring for Computer System Validation Manager jobs? Cities in Colorado with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Validation Engineer II

Validation Engineer II

Tolmar

Windsor, CO • On-site

$90K - $100K/yr

Full-time

Posted 12 days ago

Job description

Core Hours
Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
The Validation Engineer II is responsible for independently planning, executing, and documenting validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation, all in compliance with cGMP, FDA, EU, and other regulatory requirements.
Essential Duties & Responsibilities
  • Plan and coordinate validation activities for cross-functional projects, including but not limited to validation plans, protocols, and reports
  • Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
  • Lead cleaning and sterilization validation activities, including autoclaves and SIP systems.
  • Conduct risk assessments (e.g., FMEA) and support change control evaluations.
  • Analyze validation data, prepare comprehensive reports, and ensure audit readiness.
  • Collaborate with cross-functional teams, including QA, Manufacturing, Engineering, and Quality Control.
  • Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
  • Provide validation guidance and support to teams in developing and executing protocols.
  • Support investigations and CAPAs related to validation deviations or failures.
  • Contribute to continuous improvement initiatives in validation practices.
  • Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
  • Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
  • Perform other related duties as assigned.

Core Values
This position is expected to operate within the framework of Tolmar's Core Values:
  • Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
  • Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
  • Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
  • Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
  • Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities
  • Proficient in Microsoft Office Suite.
  • Knowledge of GMP regulations and validation guidelines.
  • Strong technical writing and documentation skills.
  • Excellent oral and written communication skills.
  • Effective organizational and project management skills.
  • Effective troubleshooting and problem-solving skills.
  • Ability to maintain gowning requirements for controlled areas.
  • Ability to manage multiple projects simultaneously.
  • Ability to work both independently and as part of a team.
  • Ability to develop and implement creative solutions to problems.

Education & Experience
  • Bachelor's degree in Engineering, Life Sciences, or a related technical field.
  • Minimum of 2 years' experience in validation, preferably in a sterile pharmaceutical or biotech environment.
  • Strong understanding of cGMP, FDA, and EU regulatory requirements
  • Familiarity with aseptic processing, cleanroom classifications, and environmental monitoring preferred.
  • Experience with validation software or electronic document management systems preferred.

Working Conditions
  • Working conditions include general office environment, laboratory and manufacturing setting (clean rooms where gowning is required)
  • Business demands may require working extended hours.

Compensation and Benefits
  • Pay: $90,000 to $100,000 per year depending on experience
  • Bonus eligible
  • Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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About Tolmar

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Fort Collins, CO, US

Year founded

2006

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