Senior Validation Engineer - Pharma Equipment & PLC Systems

Fagron Tech; Wichita, Northern (KS, KY); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

401(k) match

Medical insurance

Vision insurance

Dental insurance

HSA

Paid time off

Job summary

Fagron US is seeking a qualified candidate to validate pharmaceutical manufacturing equipment, perform calibration, and document validation activities across a range of systems. The role requires familiarity with PC/PLC control systems and reading P&ID drawings, along with ensuring compliance with cGMP and FDA guidance.

The ideal candidate will have a BS in engineering and 3–5 years in metrology/validation, with experience supporting regulatory inspections and quality systems.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering, or equivalent.
• 3–5 years in metrology and validation of pharmaceutical equipment.
• Experience participating in regulatory inspections and defending work.
• Working knowledge of GMP, FDA/EMA/ICH guidelines.
• Knowledge of 21 CFR Part 11 and data integrity guidance.
• Ability to handle multiple priorities and tight deadlines.
• Good verbal and written communication skills.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup).
• Read and interpret PI&D drawings, electrical, pneumatic diagrams.
• Work with PC and PLC-based control systems software/hardware.
• Ensure compliance with FDA/cGMP guidelines related to CVQ.
• Support PV and stability studies and associated documentation.

Skills

Metrology

Validation

Regulatory inspections

cGMP knowledge

Problem solving

Communication skills

Education

BS in Mechanical Engineering

BS in Industrial Engineering

BS in Automation Engineering

Tools

Kaye AVS Validator

PC & PLC control systems

Job description

Fagron US is seeking a qualified candidate to validate pharmaceutical manufacturing equipment, perform calibration, and document validation activities across a range of systems. The role requires familiarity with PC/PLC control systems and reading P&ID drawings, along with ensuring compliance with cGMP and FDA guidance.

The ideal candidate will have a BS in engineering and 3–5 years in metrology/validation, with experience supporting regulatory inspections and quality systems.