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.
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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.
