Senior Validation Engineer

About Us

Since 1990, we’ve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations across Europe, North America, South America, Africa, and Asia-Pacific, 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.

Responsibilities

• Prepare, execute, and summarize validation protocols and reports.
• Perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment, including troubleshooting and repair.
• Conduct process validation activities such as media fills and stability studies.
• Demonstrate proficiency with the Kaye AVS Validator (programming, operating, setup, etc.).
• Read and understand equipment PI&Ds, electrical, pneumatic, and arrangement drawings.
• Work with PC and PLC-based control systems software and hardware.
• Apply knowledge of FDA and cGMP guidelines related to CVQ.
• Validate and qualify utilities, distillate systems, syringe, vial and eye dropper filling machines, autoclaves, glassware and vial washers, stability chambers, drug product storage, and cleanrooms.
• Execute process validation (PV) and stability studies.
• Use rigorous logic and methods to solve difficult problems with effective solutions.
• Maintain a conscious balance between work and personal life.
• Participate in regulatory inspections and explain/defend work.

Requirements

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering and/or equivalent experience in a pharmaceutical-related discipline.
• 3 to 5 years of experience in metrology and validation of pharmaceutical manufacturing equipment.
• 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 and applicable parts of 21 CFR Part 210 and 211.
• Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
• Good verbal and written communication skills.

Benefits

• Competitive salaries.
• 401(k) plan with company matching contribution.
• Medical, vision, and dental coverage.
• 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.