ATL01-022125 Automation/Computer Systems Validation Engineer_SC jobs in United States
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Validation & Engineering Group, Inc. · 3 weeks ago

ATL01-022125 Automation/Computer Systems Validation Engineer_SC

Validation & Engineering Group, Inc. (V&EG) is a leading service provider specializing in Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We are seeking a highly skilled and dedicated professional with strong expertise in Computer Systems Validation (CSV) for Programmable Logic Controllers (PLCs) and Process Control Systems (PCS) to ensure compliance, reliability, and operational efficiency of automated systems within a regulated environment.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for PLC-based automation and process control systems in accordance with FDA 21 CFR Part 11, GAMP 5, and industry best practices
Conduct risk assessments to identify potential areas of non-compliance and develop mitigation strategies
Ensure compliance of PCS hardware, software, and applications through effective validation practices
Review and assess vendor documentation for automated control systems and test automation tools
Troubleshoot and resolve issues related to automated control systems validation
Design and implement test automation scripts for production and packaging equipment in regulated environment
Develop IQ, OQ and PQ protocols for hardware and software related to production and packaging equipment of ophthalmic products

Qualification

Computer Systems ValidationPLC systemsGAMP 5 guidelinesRisk assessmentTechnical writingProject management

Required

Bachelor's degree in Engineering or a related field
Extensive knowledge of PLC systems and automation validation
Strong understanding of GAMP 5 guidelines and other relevant regulatory requirements
Experience with instrumentation and control loop commissioning & qualification (C&Q)
Expertise in risk assessment and mitigation strategies for automated systems
Strong technical writing skills for validation documentation, reports, and investigations
Project management skills with the ability to manage multiple validation tasks effectively

Company

Validation & Engineering Group, Inc.

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Validation & Engineering Group, Proudly serving our clients since 1997.

Funding

Current Stage
Growth Stage
Total Funding
unknown
2025-08-06Acquired

Leadership Team

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Luis Puig
Partner
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Company data provided by crunchbase