Senior CSV Engineer: Validation & Automation Lead

Resilience; West Chester (Chester County); On-site; USD 85,000 - 134,000; Full time

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a CSV Engineer III to independently plan, execute, and lead validation activities across facility, automation, and computerized systems. The role emphasizes automation validation, GxP compliance, and data integrity in alignment with GAMP 5 and 21 CFR Part 11.

You will collaborate with engineering, quality, and operations to keep systems audit-ready and compliant while coaching less-experienced staff and guiding validation strategy

Qualifications

• Demonstrated experience in validation or process engineering.
• Ability to independently lead validation studies and projects from planning through execution with minimal supervision.
• Hands-on experience with automation and computer system validation (CSV).
• Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Ability to read and interpret engineering drawings, P&IDs, and system diagrams.

Responsibilities

• Independently plan, author, and execute validation deliverables for automation and computerized systems.
• Lead qualification and lifecycle management of automated equipment and GxP computer systems, including 21 CFR Part 11 and data integrity.
• Serve as a technical advisor on validation strategy and risk-based approaches.
• Lead and coordinate validation studies with minimal supervision, resolving complex issues.
• Communicate project priorities, risks, and progress to the process team.

Skills

Validation

Automation

GxP knowledge

21 CFR Part 11

Education

Bachelor's degree

Tools

Rockwell/Allen-Bradley

Siemens

Emerson DeltaV

VLM software

SCADA/DCS

Job description

Resilience, a technology-focused biomanufacturing company, seeks a CSV Engineer III to independently plan, execute, and lead validation activities across facility, automation, and computerized systems. The role emphasizes automation validation, GxP compliance, and data integrity in alignment with GAMP 5 and 21 CFR Part 11.

You will collaborate with engineering, quality, and operations to keep systems audit-ready and compliant while coaching less-experienced staff and guiding validation strategy