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Computer Systems Validation Engineer

CAIGreenville, North Carolina
On-site Full-time

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Experience Level

Experience

Qualifications

Education: Bachelor's degree in Computer Science, Engineering, or a related field; equivalent experience may be accepted. Experience: Minimum of 3 years in computer systems validation; preference for biotech or pharmaceutical experience. Knowledge: In-depth familiarity with GAMP guidelines, FDA regulations, and S88/S95 batch control standards. Skills: Strong problem-solving skills, attention to detail, and teamwork oriented.

About the job

Ready to Elevate Your Career?
Join CAI, a distinguished employee-owned professional services firm founded in 1996, boasting a global team of over 700 dedicated professionals. We specialize in commissioning, qualification, validation, startup, project management, and consulting services aimed at achieving operational readiness in FDA-regulated and other critical sectors.
Our commitment is straightforward, we prioritize our clients' needs, ensure excellence in every endeavor, and are relentless in our pursuit of success.

Core Principles That Drive Us:
- Integrity in all actions
- Commitment to one another
- Contribution to society
- Vision for a sustainable future

As an employee-owned company, every individual’s achievements contribute to the collective success of the team. We strive to meet our shared goals while embodying our core values:
- Team First
- Respect for All
- Positive Attitude

Key Responsibilities:
Documentation & Compliance:
Create GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
Design and execute test protocols and scripts
Ensure compliance with 21 CFR Part 11 and data integrity standards
Review and contribute to validation plans and risk assessments

System & Industry Expertise:
Assist with CSV activities across multiple platforms including MES, DCS, SCADA, and batch systems
Work with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
Apply knowledge of GAMP and compliance requirements (21 CFR Parts 210, 211, 11)
Utilize expertise in S88/S95 batch control standards
Client Support & Technical Execution:
Engage with clients through a strong customer service approach
Conduct system assessments and recommend solutions for data integrity issues
Collaborate with client teams to ensure compliance and successful delivery of validation projects

Qualifications and Experience:
Bachelor’s degree in Computer Science, Engineering, or a related field; equivalent experience may be considered
At least 3 years of experience in computer systems validation
Preferred background in biotech or pharmaceutical industries over medical devices
Deep understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
Familiarity with S88/S95 batch control standards
Hands-on experience with Rockwell platforms and other relevant technologies is essential.

About CAI

CAI is a prominent employee-owned professional services firm dedicated to delivering top-notch solutions for operational readiness across various industries. With a strong emphasis on integrity, teamwork, and client satisfaction, we have established ourselves as a trusted partner in the FDA-regulated space.

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