Senior Validation Engineer – Pharma Equipment & Compliance

Fagron; Wichita (KS); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

401(k) with company match

Medical, vision and dental

Health Savings Account (HSA)

Holiday/paid time off

Job summary

Fagron US in Wichita, KS is seeking a qualified validation professional to validate and calibrate pharmaceutical manufacturing equipment, including PLC-based control systems, and to document validation activities and troubleshooting.

The role involves preparing validation protocols, reviewing PI&ID drawings, participating in regulatory inspections, and supporting PV and stability studies. A BS in engineering and 3–5 years in metrology/validation are preferred.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering or equivalent pharma experience.
• 3–5 years of metrology and validation experience for pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and defending work.
• Knowledge of injectable pharmaceutical industry; sterile compounding preferred.
• Working knowledge of GMP regulations, 21 CFR Part 11, Eudralex Annex 11 and Data Integrity guidance.
• Ability to manage multiple priorities and tight deadlines with attention to detail.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.).
• Read and understand equipment PI&D drawings, electrical and pneumatic layouts.
• Working knowledge of PC and PLC-based control systems software and hardware.
• Support PV and Stability studies; ensure compliance with FDA and cGMP guidelines.
• Troubleshoot and repair validation-related issues on various equipment.

Skills

Validation engineering

PLC control systems

Equipment metrology

Regulatory inspections

FDA & GMP knowledge

Education

BS in Mechanical/Industrial/Automation/Chemical Engineering

Tools

Kaye AVS Validator

PC & PLC software

Job description

Fagron US in Wichita, KS is seeking a qualified validation professional to validate and calibrate pharmaceutical manufacturing equipment, including PLC-based control systems, and to document validation activities and troubleshooting.

The role involves preparing validation protocols, reviewing PI&ID drawings, participating in regulatory inspections, and supporting PV and stability studies. A BS in engineering and 3–5 years in metrology/validation are preferred.