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Csv Engineer Jobs (NOW HIRING)

TekWissen LLC

Senior Validation Engineer

Portsmouth, NH · On-site

$35 - $45/hr

Hybrid Summary The CSV Engineer will act as an individual contributor responsible for ensuring compliance of computerized systems with regulatory requirements and industry standards. The role focuses ...

Weil Group, Inc.

CSV Specialist

Manati, PR · On-site

Bachelor's Degree in Engineering or Computer Science combined with three (3) years of CSV and Change Control Management working experience. * Experience must be within a pharmaceutical environment ...

Weil Group, Inc

CSV Specialist

Manati, PR

Bachelor's Degree in Engineering or Computer Science combined with three (3) years of CSV and Change Control Management working experience. * Experience must be within a pharmaceutical environment ...

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How much do csv engineer jobs pay per year?

As of Jun 5, 2026, the average yearly pay for csv engineer in the United States is $99,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,000.00 and $116,500.00 per year, depending on experience, location, and employer.

What is a CSV Engineer job?

A CSV (Computer System Validation) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, comply with regulatory requirements. They develop validation protocols, perform testing, document results, and ensure adherence to industry standards like FDA 21 CFR Part 11 and GAMP 5. Their goal is to confirm that software and hardware systems function correctly, maintain data integrity, and meet compliance requirements.

What are the key skills and qualifications needed to thrive in the Csv Engineer position, and why are they important?

To thrive as a CSV Engineer (Computer System Validation Engineer), you need a solid understanding of validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or information technology. Familiarity with validation lifecycle documentation, risk assessment tools, and industry-standard systems like SAP, LIMS, and TrackWise is highly valued, as are certifications such as GAMP or Six Sigma. Strong attention to detail, analytical thinking, and excellent communication skills help CSV Engineers collaborate efficiently with cross-functional teams and ensure thorough documentation. These skills are crucial to guarantee that computerized systems in regulated industries meet compliance requirements, supporting product quality and patient safety.

What are the common challenges faced by a CSV Engineer in the pharmaceutical or medical device industry?

CSV Engineers in the pharmaceutical or medical device industry often face the challenge of keeping up with evolving regulatory requirements and ensuring all computerized systems remain compliant throughout their lifecycle. Managing comprehensive documentation, coordinating with multiple departments, and troubleshooting complex system changes can add to the workload. Successful CSV Engineers are proactive about staying informed of regulatory updates, are highly organized, and collaborate closely with Quality Assurance, IT, and operations teams. This dynamic environment offers the opportunity to learn continuously, develop expertise in validation best practices, and advance into leadership or specialized quality roles.
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Csv Engineer jobs near you
Infographic showing various Csv Engineer job openings in the United States as of May 2026, with employment types broken down into 4% Internship, 8% Full Time, 25% Part Time, 3% Temporary, 56% Contract, and 4% Nights. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution, with an average salary of $99,411 per year, or $47.8 per hour.
Sr Quality Automation and CSV Engineer (Onsite)

Sr Quality Automation and CSV Engineer (Onsite)

Tolmar

Windsor, CO • On-site

Full-time

Posted 3 days ago

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
  • Annual pay range $125,000 - $135,000 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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