CSV Engineer — Industrial Automation for Life Sciences

Inc. (Vti); California; On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Matching 401K

Excellent benefits

Professional development

Job summary

VTI Life Sciences, based in San Diego, seeks a seasoned CSV Specialist with Industrial Automation knowledge to validate computerized systems in regulated environments. You will develop and execute validation protocols, assess risk, and support lifecycle validation for PLC/SCADA controlled manufacturing systems.

Ideal candidates have 7+ years in FDA-regulated industries, strong knowledge of 21 CFR Part 11, Data Integrity, ISO 13485, and GAMP 5, plus hands-on experience with Rockwell Automation

Qualifications

• Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
• 7+ years of FDA-regulated industry experience.
• Experience with regulatory requirements: 21 CFR Part 11, 820; Data Integrity; ISO 13485; GAMP 5.
• Familiarity with Python and test scripts.
• 3+ years of SQL and Computerized Systems Validation experience.
• Experience in FDA-regulated environments and with automation equipment (HMI, robotic systems, vision sensors).
• Rockwell Automation, PLC programming, and industrial automation architecture expertise.

Responsibilities

• Authoring and executing software testing, FAT, SAT, IQ, OQ, and validation protocols.
• Drafting and reviewing CQ, IQ, OQ, PQ with Final Report.
• Scheduling and executing qualification activities.
• Collecting and analyzing qualification data against acceptance criteria.
• Drafting/ reviewing User and Software Requirements Specifications.
• Drafting/ reviewing Software Design Specifications.
• Document generation and updates (SOPs, PFMEA, forms).
• Provide services in accordance with FDA cGxP guidelines.

Skills

Python

SQL

Data Integrity

FDA Part 11

cGxP

IQ/OQ/PQ

PLC programming

Rockwell Automation

Education

Bachelor's degree or higher in Engineering or Life Sciences

Tools

Rockwell Automation

FactoryTalk View

Job description

VTI Life Sciences, based in San Diego, seeks a seasoned CSV Specialist with Industrial Automation knowledge to validate computerized systems in regulated environments. You will develop and execute validation protocols, assess risk, and support lifecycle validation for PLC/SCADA controlled manufacturing systems.

Ideal candidates have 7+ years in FDA-regulated industries, strong knowledge of 21 CFR Part 11, Data Integrity, ISO 13485, and GAMP 5, plus hands-on experience with Rockwell Automation