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Csv Validation Engineer Jobs in Colorado (NOW HIRING)

Lancesoft

Sr Packaging Engineer - Exempt

Lafayette, CO · On-site

$60 - $70/hr

Computer System Validation (CSV) * Manufacturing, Packaging and Laboratory Equipment * Technical ... Packaging engineering experience in regulated medical device or other regulated industries

Lancesoft INC

Sr Packaging Engineer

Lafayette, CO · On-site

$60 - $65/hr

Computer System Validation (CSV) * Manufacturing, Packaging and Laboratory Equipment * Technical ... Packaging engineering experience in regulated medical device or other regulated industries

Lancesoft INC

Sr Packaging Engineer

Lafayette, CO · On-site

$60 - $65/hr

Computer System Validation (CSV) * Manufacturing, Packaging and Laboratory Equipment * Technical ... Packaging Engineering experience in regulated medical device or other regulated industries ...

Natera

Software Test Engineer

Boulder, CO

Knowledge of software development lifecycle (SDLC) and validation frameworks (e.g., CSV, GxP ... Experience working cross-functionally with engineering, bioinformatics, and quality teams

Natera

Software Test Engineer

Boulder, CO · On-site

Knowledge of software development lifecycle (SDLC) and validation frameworks (e.g., CSV, GxP ... Experience working cross-functionally with engineering, bioinformatics, and quality teams

Stefanini Group

IT Specialist II

Aurora, CO

Bachelor's degree in computer science, Information Systems, Engineering, or a related technical ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini

IT Specialist II

Aurora, CO · On-site

Bachelor's degree in computer science, Information Systems, Engineering, or a related technical ... Validation (CSV)Hands-on experience supporting MES/LES platforms in production, quality, and ...

New

Stefanini Group

IT Specialist II

Aurora, CO

Bachelor's degree in computer science, Information Systems, Engineering, or a related technical ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Specialist II

Aurora, CO

Bachelor's degree in computer science, Information Systems, Engineering, or a related technical ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Specialist II

Aurora, CO · On-site

$35 - $40/hr

Bachelor's degree in computer science, Information Systems, Engineering, or a related technical ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Mace

OT/MES Implementation Project Scheduler

Denver, CO · On-site

Schedule PLC/DCS programming, SCADA configuration, and system integration activities * Plan for ... Integrate CSV (Computer System Validation) activities into OT/MES schedules * Schedule IQ/OQ/PQ, or ...

Agilent

Principal Automation Engineer

Frederick, CO · On-site

$146K - $229K/yr

Support Commissioning, Qualification, Validation (CQV) activities and function as primary point of ... Exposure to CSV/MES/DCS/PCS/SCADA/PLC/LIMS/EBR/QMS/PDH * Tools: Agile PLM, MS Project/Smartsheet ...

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Csv Validation Engineer information

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$77

How much do csv validation engineer jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for csv validation engineer in Colorado is $46.68, according to ZipRecruiter salary data. Most workers in this role earn between $34.90 and $56.35 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CSV validation engineer, and why are they important?

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What is a CSV validation engineer?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV validation engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

What are popular job titles related to Csv Validation Engineer jobs in Colorado? For Csv Validation Engineer jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Csv Validation Engineer jobs in Colorado look for? The top searched job categories for Csv Validation Engineer jobs in Colorado are:
What cities in Colorado are hiring for Csv Validation Engineer jobs? Cities in Colorado with the most Csv Validation Engineer job openings:
Csv Validation Engineer jobs near you
Infographic showing various Csv Validation Engineer job openings in Colorado as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $97,090 per year, or $46.7 per hour.

Sr Quality Automation and CSV Engineer (Onsite)

Tolmar

Windsor, CO • On-site

$138K - $148K/yr

Full-time

Re-posted 6 days ago

Tolmar rating

9.8

Company rating: 9.8 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

1st of 86 rated pharmaceutical

Job description

Core Hours: Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
The Senior Automation CSV Engineer will lead the design, implementation, and validation of automated systems and new technology solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.
Essential Duties & Responsibilities
  • Automation and Computer System Validation:
    • Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA's CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
    • Perform risk assessments and ensure data integrity
    • Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports).
  • System Lifecycle Management:
    • Oversee system implementation, upgrades, and change control for automation and computer systems.
    • Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems.
  • Regulatory Compliance:
    • Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing.
    • Support audits and inspections by providing validation evidence and technical expertise.
  • Innovation & Continuous Improvement:
    • Identify opportunities to integrate new technologies and advanced analytics for process optimization and predictive maintenance.
    • Drive digital transformation initiatives.
  • Quality Oversight & Approval:
    • Provide independent quality oversight for automation and computer system validation activities.
    • Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity.
    • Act as a quality representative during system implementation and qualification phases.
  • Adhere to company and departmental timelines with high accuracy and quality.
  • Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.
  • Performs other 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
  • Excellent organizational and project management skills.
  • Excellent oral and written communication skills.
  • Ability to work independently with minimal supervision and as part of a cross-functional team.
  • Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
  • Strong project management and cross-functional leadership skills.
  • Ability to author strong technical reports free of errors.
  • Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs.
  • Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering and the role of human interaction for process engineering and establishment of trustworthy data.
  • Advanced troubleshooting and problem-solving skills.
  • Ability to manage multiple projects concurrently and under tight time constraints.

Education & Experience
  • Bachelor's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required
  • Master's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred
  • Minimum of 8 years' experience in pharmaceutical automation and computerized system validation.
  • Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance.
  • Proficiency in risk-based validation and data integrity principles.

Working Conditions
  • Working conditions include general office environment.
  • Business demands may require working extended hours.

Compensation and Benefits
  • Pay: $138,000 to $148,000 per year depending on experience
  • Bonus Eligible
  • Benefits information: 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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