Overview
On Site
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 6+ MO
Skills
GMP
Reporting
IQ
OQ
PQ
Technical Writing
Acceptance Testing
System Testing
Regulatory Compliance
Data Integrity
Programmable Logic Controller
HMI
Documentation
Change Control
Management
Corrective And Preventive Action
Pharmaceutics
Life Sciences
Siemens
GAMP
Computerized System Validation
Communication
Collaboration
Oracle UCM
SANS
OM
WebKit
IMG
Job Details
Title - CSV Automation Engineer (Onsite)
Location: North Kansas City, KS (Onsite)
Duration: 3-6 Months (most likely 6)
Industry: Pharmaceutical
Duration: 3-6 Months (most likely 6)
Industry: Pharmaceutical
Job Description:
We are currently seeking a highly experienced Computer System Validation (CSV) Automation Engineer to join an active pharmaceutical project in North Kansas City, KS. The engineer will play a key role in ensuring validated automation systems meet both regulatory and technical standards in a dynamic and fast-paced environment.
The ideal candidates will have strong technical knowledge of automation systems (Rockwell, Siemens, Unicorn) and extensive experience with GMP-compliant validation practices. Immediate onsite availability is required.
Responsibilities:
Perform comprehensive Computer System Validation (CSV) activities, including requirements review, protocol development, execution, and reporting (IQ/OQ/PQ).
Review and validate technical documentation, design specifications, and system configurations.
Support and lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for automation and control systems.
Conduct system testing to ensure compliance with FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
Collaborate with cross-functional teams to support PLC and HMI system configuration, troubleshooting, and lifecycle documentation.
Provide guidance in change control, deviation management, and CAPA processes in a regulated environment.
Key Requirements:
Review and validate technical documentation, design specifications, and system configurations.
Support and lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for automation and control systems.
Conduct system testing to ensure compliance with FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
Collaborate with cross-functional teams to support PLC and HMI system configuration, troubleshooting, and lifecycle documentation.
Provide guidance in change control, deviation management, and CAPA processes in a regulated environment.
Key Requirements:
10+ years of experience in Computer System Validation (CSV) & Automation Engineering, or related disciplines within pharmaceutical or life sciences industries.
Proven expertise with Rockwell Automation platforms; working knowledge of Siemens and Unicorn (Waters) is a strong plus.
Deep understanding of FDA regulations, GAMP guidelines, and CSV methodologies.
Ability to thrive in fast-paced, high-pressure project environments with shifting priorities.
Excellent communication and collaboration skills.
Must be comfortable working onsite and able to start immediately.
Proven expertise with Rockwell Automation platforms; working knowledge of Siemens and Unicorn (Waters) is a strong plus.
Deep understanding of FDA regulations, GAMP guidelines, and CSV methodologies.
Ability to thrive in fast-paced, high-pressure project environments with shifting priorities.
Excellent communication and collaboration skills.
Must be comfortable working onsite and able to start immediately.
Himanshu Goswami
Sr. IT Technical Recruiter
Stellent IT Phone:
Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom
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