Pharma Validation Engineer II — Impact & Compliance Expert

Fagron; Canton (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health Savings Account (HSA)

Paid holidays

Job summary

Fagron in Canton, MA seeks a Validation Engineer to validate pharmaceutical manufacturing equipment, PLC/control systems, and perform calibration/validation activities including PV and stability studies.

Requirements include a BS in engineering and 3–5 years in metrology/validation within a cGMP environment, familiarity with 21 CFR Part 11, and experience with regulatory inspections. Competitive benefits offered.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering or equivalent pharmaceutical experience.
• 3–5 years in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and explaining/defending work.
• Working knowledge of GMP regulations and 21 CFR Part 11.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Read and interpret P&IDs, electrical, pneumatic and arrangement drawings.
• Work with PC and PLC-based control systems software/hardware and PV/stability studies.
• Ensure compliance with FDA, EMA, ICH guidelines and data integrity requirements.

Skills

Equipment validation

PLC and control systems

Calibration & validation

Education

BS in Mechanical/Industrial Automation/C&E Engineering

Tools

Kaye AVS Validator

Job description

Fagron in Canton, MA seeks a Validation Engineer to validate pharmaceutical manufacturing equipment, PLC/control systems, and perform calibration/validation activities including PV and stability studies.

Requirements include a BS in engineering and 3–5 years in metrology/validation within a cGMP environment, familiarity with 21 CFR Part 11, and experience with regulatory inspections. Competitive benefits offered.