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Computer Systems Validation Engineer at CAI | Indianapolis, Indiana

CAIIndianapolis, Indiana
On-site Full-time

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Key Responsibilities:Documentation & ComplianceCraft GxP computer validation documentation, including URS, FRS, RTM, and summary reports. Develop and execute comprehensive test protocols and scripts. Ensure compliance with 21 CFR Part 11 and uphold data integrity standards. Review and contribute to validation plans and conduct risk assessments. System & Industry ExpertiseFacilitate Computer Systems Validation (CSV) activities across various platforms, including MES, DCS, SCADA, and batch systems. Engage with widely-used systems 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, and Wonderware. Apply expertise in GAMP guidelines and compliance regulations (21 CFR Parts 210, 211, 11). Utilize knowledge of S88/S95 batch control standards. Client Support & Technical ExecutionProvide exceptional client support with a strong customer-service focus. Conduct system assessments and implement remediation strategies related to data integrity. Collaborate effectively with client teams to ensure validation compliance and successful project delivery.

About the job

Are You Prepared to Make a Difference?
CAI, a fully employee-owned professional services firm founded in 1996, has expanded to over 700 dedicated professionals globally. We specialize in commissioning, qualification, validation, startup, project management, and other consulting services essential for operational readiness in FDA-regulated and other critical industries.
Our mission is straightforward—we prioritize our clients' needs, strive for excellence, and commit to achieving the best outcomes.

Our Core Values:
- Integrity in all we do
- Commitment to supporting one another
- Dedication to societal service
- Focus on our collective future

Being employee-owned means that every individual's success contributes to the success of the whole team. We work collaboratively to meet our objectives while embodying our core principles:
- Team Over Self
- Respect for All
- Positive Attitude

This position is based in Indianapolis, Indiana but may also report to Rockville, MD or Frederick, MD.

About CAI

CAI is an employee-owned firm that emphasizes integrity, teamwork, and commitment to societal needs. With a vision focused on operational readiness for FDA-regulated sectors, CAI provides unparalleled consulting services across a range of critical industries.

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