Senior Validation Engineer, Pharma GMP & Equipment

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 90,000 - 130,000; Full time

Job summary

Fagron Sterile Services US (FSS) is seeking a qualified professional to validate pharmaceutical manufacturing equipment and PLC-based control systems. You will perform calibration/validation activities including media fills and stability studies, ensuring adherence to cGMP and FDA guidelines.

Responsibilities include executing validation protocols, interpreting P&IDs and drawings, and working with utilities and filling/sterile systems.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering or equivalent pharma experience.
• 3–5 years in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and defending work.
• Knowledge of injectable pharma, sterile compounding preferred.
• Experience with cGMP environments and FDA/EU guidelines (21 CFR Part 11, Annex 11).
• Familiarity with GMP regulations and data integrity guidance.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup).
• Read and interpret equipment P&IDs, electrical, pneumatic and layout drawings.
• Work with PC and PLC-based control systems software and hardware.
• Apply FDA and cGMP guidelines relevant to CVQ.
• Validate and qualify utilities, distillate systems, filling machines, autoclaves, cleanrooms, and stability chambers.
• Conduct PV and stability studies as part of validation programs.
• Demonstrate functional and technical knowledge to perform at a high level.
• Use rigorous methods to solve complex problems with effective solutions.
• Balance work and personal life to maintain focus and quality.

Skills

Metrology

Validation

Regulatory inspections

Problem solving

Written communication

Education

BS in Mechanical, Industrial, Automation, or Chemical Eng.

Tools

Kaye AVS Validator

PLC control systems

Job description

Fagron Sterile Services US (FSS) is seeking a qualified professional to validate pharmaceutical manufacturing equipment and PLC-based control systems. You will perform calibration/validation activities including media fills and stability studies, ensuring adherence to cGMP and FDA guidelines.

Responsibilities include executing validation protocols, interpreting P&IDs and drawings, and working with utilities and filling/sterile systems.