Validation Engineer II - Pharma Equipment & Systems

Fagron Tech; Canton (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401(k) plan with company match

Health, vision and dental benefits

HSA

Job summary

Fagron US is seeking a qualified Validation Engineer to validate and qualify pharmaceutical manufacturing equipment, perform instrument calibration, and support process validation activities across a range of systems.

The role requires knowledge of GMP regulations, experience with PV and stability studies, and the ability to read PI&Ds and drawings. A BS in engineering and 3–5 years in metrology/validation are expected.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering, or equivalent experience.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup).
• Read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.
• Work with PC and PLC-based control systems software/hardware.
• Ensure compliance with FDA and cGMP guidelines related to CVQ.

Skills

Metrology

Validation

PLC Systems

cGMP

Engineering Drawings

Documentation

Problem Solving

Education

BS in Engineering

Tools

Kaye AVS Validator

PI&Ds Reading

Job description

Fagron US is seeking a qualified Validation Engineer to validate and qualify pharmaceutical manufacturing equipment, perform instrument calibration, and support process validation activities across a range of systems.

The role requires knowledge of GMP regulations, experience with PV and stability studies, and the ability to read PI&Ds and drawings. A BS in engineering and 3–5 years in metrology/validation are expected.