Senior Validation Engineer – Pharmaceutical Equipment & PLC

Fagron Nederland BV; Wichita, Northern (KS, KY); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, Vision and Dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron US in Wichita, KS is seeking a Validation Specialist with hands-on experience validating pharmaceutical manufacturing equipment and control systems. You will prepare, execute and document validation protocols and reports, and support process validation activities such as media fills and stability studies.

You have a BS in engineering and 3–5 years in metrology/validation, familiar with cGMP, FDA/EMA guidelines, and regulatory inspections.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering or equivalent experience.
• 3–5 years of experience in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and explaining/defending work.
• Knowledge of GMP regulations and FDA/cGMP guidelines.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup).
• Read and understand equipment P&IDs, electrical, pneumatic and arrangement drawings.
• Work with PC and PLC-based control systems software and hardware.
• Understand FDA and cGMP guidelines related to CVQ.
• Validate and qualify utilities, distillate systems, filling machines, autoclaves, glassware and cleanrooms.
• Contribute to PV and stability studies.
• Apply rigorous analysis to solve complex problems.
• Maintain work-life balance.

Skills

Metrology experience

Validation of pharmaceutical equipment

Regulatory inspections experience

cGMP knowledge

Education

BS degree in Mechanical/Industrial/Automation/Chemical Engineering

Tools

Kaye AVS Validator

Job description

Fagron US in Wichita, KS is seeking a Validation Specialist with hands-on experience validating pharmaceutical manufacturing equipment and control systems. You will prepare, execute and document validation protocols and reports, and support process validation activities such as media fills and stability studies.

You have a BS in engineering and 3–5 years in metrology/validation, familiar with cGMP, FDA/EMA guidelines, and regulatory inspections.