Senior Validation Engineer — Pharma Equipment & PLC Systems

Fagron Tech; Wichita (KS); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision and dental insurance

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron Tech seeks a qualified professional to validate pharmaceutical manufacturing equipment and PLC/CB controls. You will prepare, execute, and document validation protocols and reports, and support regulatory inspections in a cGMP environment.

Responsibilities include calibration, PV and stability studies, and reading PI&D drawings, with familiarity of 21 CFR Part 11 and related guidance. A BS in engineering and 3–5 years of metrology experience are preferred.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering and/or equivalent pharma discipline.
• 3–5 years in metrology and validation of pharmaceutical manufacturing equipment.
• Experience in regulatory inspections and defending work.
• Knowledge of the injectable pharmaceutical industry and sterile compounding preferred.
• Experience in cGMP environments and FDA/EMA/ICh guidelines.
• Familiarity with GMP regs including 21 CFR Part 11 and Data Integrity guidance.

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, electrical, pneumatic drawings.
• Work with PC and PLC-based control systems software and hardware.
• Ensure compliance with FDA/cGMP guidelines related to CVQ.
• Validate utilities, distillate systems, filling machines, autoclaves, glassware, stability chambers.
• Support PV and stability studies and regulatory inspections.

Skills

Metrology

Validation

PLC & CB control systems

PI&D drawings

Regulatory inspections

cGMP knowledge

Communication

Multitasking

Education

BS in Mechanical/Industrial/Automation/Chemical Engineering

Tools

Kaye AVS Validator

PC software basics

Job description

Fagron Tech seeks a qualified professional to validate pharmaceutical manufacturing equipment and PLC/CB controls. You will prepare, execute, and document validation protocols and reports, and support regulatory inspections in a cGMP environment.

Responsibilities include calibration, PV and stability studies, and reading PI&D drawings, with familiarity of 21 CFR Part 11 and related guidance. A BS in engineering and 3–5 years of metrology experience are preferred.