Senior CSV Engineer: Industrial Automation & GMP Validation

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

Benefits offered by this job

401K matching

Competitive compensation

Professional development

Travel opportunities

Job summary

VTI Life Sciences in San Diego seeks a forward-thinking CSV Specialist with Industrial Automation knowledge to validate systems in regulated environments. You will develop and execute validation protocols, risk assessments and documentation for lifecycle support of cGxP systems, including PLC/SCADA manufacturing controls.

The role requires hands-on validation, data integrity focus, and experience with Rockwell Automation suites and FactoryTalk View, along with strong technical writing and

Qualifications

• Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
• 7+ years of FDA-regulated industry experience.
• Expertise in 21 CFR Part 11/820, Data Integrity, ISO 13485 and GAMP 5.
• Familiarity with Python and test scripts.
• 3+ years in SQL, Software Validation and CSV.
• Experience in FDA-regulated environments and automation equipment.
• Rockwell Automation and FactoryTalk View experience required.
• Strong documentation, MS Office proficiency and cGMP knowledge.

Responsibilities

• Authoring and executing Software Testing, FAT, SAT, IQ, OQ, and validation protocols.
• Drafting CQ/IQ/OQ/PQ with final report, and coordinating qualification activities.
• Collecting and analyzing qualification data against acceptance criteria.
• Drafting/reviewing USER/Software Requirements Specifications.
• Design specification drafting and review.
• Documentation generation and updates (SOPs, PFMEA, forms).
• Attend meetings and coordinate projects.
• Provide services in line with FDA cGxP guidelines and regulations.

Skills

Regulatory compliance

Industrial automation knowledge

Technical writing

Project coordination

Python scripting

SQL

Data integrity

Documentation

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Rockwell Automation

FactoryTalk View

SQL Server

HMI/SCADA systems

Job description

VTI Life Sciences in San Diego seeks a forward-thinking CSV Specialist with Industrial Automation knowledge to validate systems in regulated environments. You will develop and execute validation protocols, risk assessments and documentation for lifecycle support of cGxP systems, including PLC/SCADA manufacturing controls.

The role requires hands-on validation, data integrity focus, and experience with Rockwell Automation suites and FactoryTalk View, along with strong technical writing and