Senior Validation Engineer

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

Who We Are

Since 1990, weve grown into a global leader in personalized medicine.

Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better.

We're passionate, science-driven, and always looking for new ways to improve lives.

About The Job

The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems.

Perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment and troubleshooting and repair and, process validation i.e., media fills and stability studies.

Key Responsibilities

• [Prepare, execute and summarize validation protocols and reports.
• [Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.).
• [Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.]
• [Working knowledge of PC and PLC base control systems software and hardware.]
• [Working knowledge of FDA and cGMP guidelines as related to CVQ.]
• [Experience validating and qualifying, but not limited to Utilities, Distillate Systems, Syringe, Vial and Eye Dropper Filling Machines, Autoclaves, Glassware and Vial Washers, Stability Chambers Drug Product Storage and Cleanrooms.]
• [Experience with PV and Stability studies.]
• [Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.]
• [Uses rigorous and logic and methods to solve difficult problems with effective solutions.]
• [Maintains a conscious balance between work and personal life as to not allow one to dominate the other.]

Basic Qualifications

• [BS degree in Mechanical, Industrial, Automation, or Chemical Engineering. and/or equivalent experience in pharmaceutical related discipline.]
• [3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.]
• [Experience participating in regulatory inspections and explaining/defending work.]
• [General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.]
• [Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.]
• [Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.]
• [Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).]
• [Knowledge of GMP including international regulations.]
• [Knowledge of applicable parts of 21 CFR Part 210, and 211 regulations and guidance.]
• [Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.]
• [Good verbal and written communication skills.]