Senior CSV Engineer – Automation & Validation Lead

Resilience

Olde West Chester (OH)

On-site

USD 85,000 - 134,000

Full time

5 days ago
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Benefits offered by this job

Bonus program
401(k) matching
Healthcare benefits
Family benefits
Life and disability insurance
Paid vacation and holidays
Tuition reimbursement
Caregiver support

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 CSV.

The role partners with engineering, quality, and operations to keep systems compliant and inspection-ready, applying independent technical judgment and coaching less-experienced team members. Occasional nonstandard hours may be required.

Qualifications

  • Bachelor’s degree in Engineering, Computer Science, or related discipline.
  • 5+ years of validation or process engineering experience.
  • Hands-on automation and computer system validation (CSV).
  • Knowledge of GxP and validation standards (21 CFR Part 11, GAMP 5, ALCOA+).
  • Ability to read engineering drawings, P&IDs, and system diagrams.
  • Strong communication and problem-solving skills.

Responsibilities

  • Independently plan, author, and execute validation deliverables (IQ/OQ/PQ) for automation and computer systems per GAMP 5 and cGMP.
  • Lead qualification and lifecycle management of automated equipment and GxP computer systems (PLC/SCADA/DCS) including 21 CFR Part 11 and data integrity.
  • Serve as a technical advisor on validation strategy and risk-based approaches across multiple domains.
  • Lead validation studies and investigations with minimal supervision; coordinate across teams.
  • Communicate priorities, risks, and progress to the process team; drive continuous-improvement in validation practices.
  • Coach and mentor less-experienced engineers and technicians.

Skills

Validation
Automation
CSV
GAMP 5
21 CFR Part 11
ALCOA+
P&ID interpretation

Education

Bachelor’s degree in Engineering or related

Tools

Rockwell/Allen-Bradley
Siemens
Emerson DeltaV

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 CSV.

The role partners with engineering, quality, and operations to keep systems compliant and inspection-ready, applying independent technical judgment and coaching less-experienced team members. Occasional nonstandard hours may be required.

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