Pharma GMP Process Engineer I

Novartis; Durham (NC); On-site; USD 41,000 - 76,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Vacation and holidays

Job summary

Novartis is seeking a Process Engineer I or II to provide engineering, validation and maintenance support for process manufacturing equipment, facilities and utilities at the site. The role covers equipment qualification, preventive maintenance, calibration, and vendor coordination to ensure compliant operations.

The position requires a BS in Chemical, Electrical, or Mechanical Engineering with relevant GMP experience, strong communication, and teamwork skills.

Qualifications

• Excellent oral and written communication skills.
• Strong teamwork and organizational abilities.
• Knowledge of FDA regulations and GMP systems.
• Ability to apply engineering principles to maintain validated equipment.

Responsibilities

• Ensure equipment is designed/qualified and maintained in a validated state.
• Perform preventive maintenance activities as equipment owner.
• Coordinate maintenance, calibration, and qualification with external vendors.
• Provide engineering, validation and maintenance support for process equipment, facilities and utilities.
• Own minor to medium changes to process equipment to maintain validation.
• Investigate deviations and implement corrective actions.
• Participate in FDA/internal audits as SME and respond to observations.

Skills

Excellent communication

Teamwork

Technical writing

FDA GMP awareness

Education

BS in Chemical Engineering

BS in Electrical Engineering

BS in Mechanical Engineering

Job description

Novartis is seeking a Process Engineer I or II to provide engineering, validation and maintenance support for process manufacturing equipment, facilities and utilities at the site. The role covers equipment qualification, preventive maintenance, calibration, and vendor coordination to ensure compliant operations.

The position requires a BS in Chemical, Electrical, or Mechanical Engineering with relevant GMP experience, strong communication, and teamwork skills.