Senior Validation Engineer

at Fagron Sterile Services in Wichita, Kansas, United States

Job Description

Since 1990, we’ve 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-Pacific and 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. 🚀

Explore your future at Fagron Career Site.

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.

• 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.

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

We’re proud to be an equal opportunity employer. 🌍 Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.