Senior CSV Engineer - Validation & Automation

Resilience; Cincinnati (OH); On-site; USD 85,000 - 134,000; Full time

Benefits offered by this job

Annual bonus program

401(k) with company match

Comprehensive healthcare

Job summary

Resilience is seeking a CSV Engineer III to independently plan, execute, and lead validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV).

As a technical advisor, you will coach team members, coordinate validation studies, and ensure results are audit-ready in a cGMP environment. This role requires strong analytical skills and proven problem solving.

Qualifications

• Hands-on experience with automation and computer system validation (CSV).
• Experience validating systems in GxP/regulatory environments.
• Strong written and verbal communication and documentation skills.
• Ability to lead validation studies from planning through execution.
• Familiarity with SDLC, configuration management, and validation lifecycle.

Responsibilities

• Independently plan, author, and execute validation deliverables (IQ/OQ/PQ) for automation and computerized systems.
• Lead lifecycle management of automated equipment and GxP computer systems with data integrity compliance.
• Coach and coordinate validation activities across engineering, quality, and operations.
• Provide technical guidance on validation strategy and risk-based approaches.
• Communicate priorities, risks, and progress to stakeholders regularly.

Skills

Automation & CSV

Data integrity (ALCOA+)

GxP regulations

Reading P&IDs

Problem solving

Technical communication

Coaching others

Independent judgment

Education

Bachelor’s degree in Engineering/CS or related

Tools

Rockwell/Allen-Bradley

Siemens

Emerson DeltaV PLC/SCADA/DCS

GAMP 5

21 CFR Part 11

Job description

Resilience is seeking a CSV Engineer III to independently plan, execute, and lead validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV).

As a technical advisor, you will coach team members, coordinate validation studies, and ensure results are audit-ready in a cGMP environment. This role requires strong analytical skills and proven problem solving.