Computer Systems Validation Engineer

Job Description

Job Description

ARE YOU PASSIONATE ABOUT DRIVING COMPLIANCE, ENSURING SYSTEM INTEGRITY, AND ELEVATING QUALITY STANDARDS?

Tentamus North America is searching for a skilled Computer Systems Validation Engineer to lead validation efforts, strengthen regulatory compliance, and support the implementation of high-quality, risk-based IT and laboratory systems. This role is ideal for someone with deep knowledge of cGMP, a strong analytical mindset, and the ability to translate complex technical requirements into compliant, reliable solutions.

If you excel in dynamic environments, enjoy solving challenges that directly impact product quality and patient safety, and thrive at the intersection of technology and regulatory compliance, we want to hear from you!

WHAT YOU'LL DO AS THE CSV ENGINEER

The CSV Engineer performs validation services, including but not limited to equipment qualification, method validation, protocol generation and execution, data analysis and reporting; Generating, executing, and reviewing validation protocols and reports for equipment, instruments, utilities, and control systems through : Commissioning, (ERES), VP, FDS, DS, URS, IQ, OQ, PQ, VSR phases. Other duties include :

Validation Documentation & Execution

• Author, review, approve, and execute validation documentation, including protocols, summary reports, procedures, and other lifecycle documents.
• Design, implement, and support validation strategies and protocols for products, raw materials, and development projects.
• Provide URS, validation plans, and risk assessments for new systems and equipment introduced to the facility.
• Provide technical support for validation activities associated with Quality Control testing processes.

Compliance, cGMP, and Quality Assurance

Validation Support & Troubleshooting

Cross-Functional Collaboration & Representation

Continuous Improvement & Digitalization

Skills & Technical Competencies

SCHEDULE & POSITION

This is a full-time, Monday – Friday, hybrid position. Occasional evening and weekend work may be required for performance tests or software rollouts, and domestic travel up to 20% may be necessary for project implementation, collaboration, and / or learning and development purposes. This role primarily operates in an office environment, but we offer flexibility for remote work based on organizational needs. Collaboration with multiple departments and teams is essential.

Our ideal candidate will be located near one of our laboratories in Portland, Oregon, Dallas / Fort Worth, Texas, or Fredericksburg, Virginia.

MENTAL & PHYSICAL REQUIREMENTS

This role requires regular use of hands and fingers, the ability to reach, talk, and hear, and extended periods of sitting at a desk working on a computer. Specific vision abilities needed include near and far distance, color perception, peripheral vision, and depth perception.

WHAT'S IN IT FOR YOU?

This role offers an annual salary between $80,000 – $85,000, a comprehensive and low-cost benefits package including medical, HSA, dental, vision, disability, life insurance, a matching 401(k), paid time off (PTO), and access to an Employee Assistance Program.

QUALIFICATIONS

The ideal candidate will be authorized to work in the United States indefinitely and without restrictions or sponsorship, hold a Bachelor's Degree in Chemistry, Laboratory Sciences, Computer Science, or a related field preferred; equivalent experience, post-graduate education, or relevant certifications / licensure considered; other qualifications include :

ABOUT TENTAMUS

Labs for Life® . We are a global network of full-service accredited analytical laboratories providing crucial quality and safety analysis for clients locally, nationally, and beyond using proven methods of chemistry and microbiology. Many of the products you use and consume daily rely on Tentamus labs. With 20 labs in North America and growing (100 globally), we celebrate having talented diverse scientific and service-oriented professionals.

Visit us at Tentamus.com | Follow Tentamus on LinkedIn

Job Posted by ApplicantPro