GMP Process Engineer I - Pharma Manufacturing

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

Benefits offered by this job

Health benefits

401(k) with company match

Job summary

Novartis Group of Companies in Durham, NC 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.

Responsibilities include qualifying new equipment, coordinating maintenance and calibration with vendors, investigating deviations, and supporting audits. Strong communication, teamwork and knowledge of FDA/GMP requirements are essential to ensure reliable, compliant operations.

Qualifications

• B.S. degree in Chemical, Electrical or Mechanical Engineering or related field.
• Experience in pharmaceutical or biopharmaceutical GMP environments is required.
• Excellent communication and organizational skills.

Responsibilities

• Qualify new equipment and ensure existing equipment is maintained in a validated state.
• Coordinate preventive maintenance, calibration and qualification with vendors.
• Investigate deviations and implement corrective actions.
• Support FDA/internal audits as SME for facilities and equipment.

Skills

Oral & written communication

Teamwork

FDA regulations awareness

GMP knowledge

Technical writing

Education

B.S. in Chemical/Electrical/Mechanical Eng

B.S. in Chemical/Electrical/Mechanical Eng – >2 yrs exp

Job description

Novartis Group of Companies in Durham, NC 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.

Responsibilities include qualifying new equipment, coordinating maintenance and calibration with vendors, investigating deviations, and supporting audits. Strong communication, teamwork and knowledge of FDA/GMP requirements are essential to ensure reliable, compliant operations.