Validation Engineer II

Work onsite in Canton, MA as a Validation Engineer II with Fagron, a global leader in personalized medicine. You will support pharmaceutical manufacturing by validating equipment and PLC and computer-based control systems in cGMP environments, with a focus on documentation, instrumentation accuracy, and data integrity. Fagron also offers a benefits package designed to support your health and financial goals, including a 401(k) with company matching, comprehensive medical, vision, and dental, and HSA options.

What you’ll do

• Prepare, execute, and summarize validation protocols and reports.
• Demonstrate proficiency with the Kaye AVS Validator including programming, operating, and setup.
• Read and interpret equipment PI&Ds, electrical drawings, pneumatic drawings, and arrangement drawings.
• Apply working knowledge of PC and PLC-based control systems software and hardware.
• Support work in alignment with FDA and cGMP guidelines as they relate to CVQ.
• Validate and qualify manufacturing systems and equipment, including (but not limited to) utilities, distillate systems, syringe/vial filling machines, autoclaves, glassware and vial washers, stability chambers, and cleanrooms.
• Contribute to PV and stability studies.
• Use rigorous and logical problem-solving methods to address difficult issues with effective solutions.

What you bring

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

Tools and technologies

• Kaye AVS Validator
• PLC
• PC

Benefits at Fagron

• 401(k) plan with company matching contribution
• Medical, vision and dental
• Health savings account (HSA)
• Holiday and paid time off

About Fagron

Since 1990, Fagron has grown into a global leader in personalized medicine. The organization operates in +80 locations across Europe, North America, South America, Africa, and Asia-Pacific, and supports over 200,000 customers worldwide.

Salary range: USD 85,000 - 110,000 per year.