Senior Validation Engineer - Pharma Equipment & Compliance

Fagron; Wichita, Northern (KS, KY); Hybrid; USD 80,000 - 105,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron is seeking a Validation Engineer to join our manufacturing validation team in Wichita, KS. The successful candidate will validate pharmaceutical manufacturing equipment, perform instrument calibration, and support PV and stability studies in a cGMP environment.

Responsibilities include preparing validation protocols, interpreting P&IDs, and working with PLC-based control systems, ensuring compliance with FDA and global guidelines. Strong analytical and communication skills are essential.

Qualifications

• 3 to 5 years of metrology and validation experience.
• Experience participating in regulatory inspections and defending work.
• Working knowledge of FDA/EMA/ICH guidelines and cGMP.
• Knowledge of 21 CFR Part 11 and Data Integrity guidance.
• Ability to read P&IDs and equipment drawings.
• Strong verbal and written communication skills.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator.
• Read and interpret PI&Ds, electrical and pneumatic drawings.
• Work with PC and PLC-based control systems software/hardware.
• Ensure compliance with FDA and cGMP guidelines.
• Validate utilities, distillate systems, syringes, vials, autoclaves, glassware and stability chambers.
• Support PV and stability studies.
• Apply rigorous, logical problem-solving to complex issues.
• Maintain balance between work and personal life.

Skills

Metrology

Validation

Regulatory inspections

cGMP environments

Data integrity

P&IDs reading

GMP knowledge

Communication

Education

BS degree in Mechanical, Industrial, Automation, or Chemical Engineering

Tools

Kaye AVS Validator

Job description

Fagron is seeking a Validation Engineer to join our manufacturing validation team in Wichita, KS. The successful candidate will validate pharmaceutical manufacturing equipment, perform instrument calibration, and support PV and stability studies in a cGMP environment.

Responsibilities include preparing validation protocols, interpreting P&IDs, and working with PLC-based control systems, ensuring compliance with FDA and global guidelines. Strong analytical and communication skills are essential.