Senior CSV Engineer & Validation Lead

Resilience; Olde West Chester (OH); On-site; USD 85,000 - 133,750; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Health insurance

Paid time off

Job summary

Resilience seeks a seasoned Validation Leader to plan, execute, and own validation activities for automation and computer systems in a regulated biomanufacturing setting.

You will guide lifecycle management, ensure 21 CFR Part 11 compliance, and mentor engineers on best practices, risk-based approaches, and strong documentation. The role requires collaboration across engineering, quality, and operations in a fast-paced facility.

Qualifications

• Demonstrated experience in validation or process engineering.
• Demonstrated 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 expertly read and interpret engineering drawings, P&IDs, and system diagrams.
• Strong written and verbal communication skills, including technical report writing.
• Strong problem-solving abilities and sound independent judgment.
• Ability to coach peers and provide technical guidance to less-experienced team members.

Responsibilities

• Independently plan, author, and execute validation deliverables - validation plans, protocols (IQ/OQ/PQ), and summary reports - for automation and computerized systems in accordance with GAMP 5 and applicable cGMP requirements.
• Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance.
• Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio.
• Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues.
• Communicate project priorities, risks, and progress to the process team on a continuing basis.
• Identify and drive continuous-improvement opportunities in validation methodology, automation, and documentation practices.

Skills

Validation experience

Process engineering

Automation experience

CSV

GxP knowledge

Engineering drawings reading

Documentation/writing

Education

Bachelor's degree in Engineering/CS or related

Tools

Rockwell/Allen-Bradley

Siemens

Emerson DeltaV

Job description

Resilience seeks a seasoned Validation Leader to plan, execute, and own validation activities for automation and computer systems in a regulated biomanufacturing setting.

You will guide lifecycle management, ensure 21 CFR Part 11 compliance, and mentor engineers on best practices, risk-based approaches, and strong documentation. The role requires collaboration across engineering, quality, and operations in a fast-paced facility.