Manufacturing Engineer II — Validation & Sterilization

SGS Consulting; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting is seeking a validation-focused engineer to develop and maintain equipment validation protocols (IQ/OQ/PQ) for medical devices. You will lead troubleshooting and data analysis to improve manufacturing yield and reduce downtime, while coordinating with Manufacturing, Regulatory, and Quality Assurance teams.

The ideal candidate brings 4–6 years in medical device/pharma manufacturing, a BS in Engineering, and a PE or Lean/Six Sigma credentials.

Qualifications

• 4–6 years of experience in medical device/pharmaceutical manufacturing.
• Professional Engineer license preferred.
• Lean/Six Sigma training a plus.

Responsibilities

• Create, update, and maintain equipment service work instructions.
• Lead validation plans and protocols (IQ/OQ/PQ) and prepare reports.
• Support troubleshooting to minimize downtime and re-occurrence.
• Analyze data to drive manufacturing yields and improvements.
• Develop and implement change controls and CAPA investigations.
• Coordinate with cross-functional teams for regulatory submissions and audits.

Skills

FDA/OSHA/ISO requirements

Lean Six Sigma

Manufacturing Equipment

Project Management

Validation Plans/Protocols

Change Control/CAPA

Education

BS in Engineering

Professional Engineer License

Lean/Six Sigma Green/Black Belt

Job description

SGS Consulting is seeking a validation-focused engineer to develop and maintain equipment validation protocols (IQ/OQ/PQ) for medical devices. You will lead troubleshooting and data analysis to improve manufacturing yield and reduce downtime, while coordinating with Manufacturing, Regulatory, and Quality Assurance teams.

The ideal candidate brings 4–6 years in medical device/pharma manufacturing, a BS in Engineering, and a PE or Lean/Six Sigma credentials.