GMP Process Engineer I

Novartis Farmacéutica; Durham, Northern (NC, KY); Hybrid; USD 41,000 - 76,000; Full time

Job summary

Novartis Gene Therapies 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. The role covers equipment qualification, calibration, deviations, audits, and collaboration with vendors, with growth to more complex processing equipment such as bioreactors and chromatography.

Candidates should have a BS in Chemical, Electrical or Mechanical Engineering and strong

Qualifications

• BS in Chemical, Electrical or Mechanical Engineering or related field.
• Experience: Engineer I <2 years; Engineer II >2 years in pharmaceutical GMP manufacturing operations.
• Excellent oral and written communication skills.
• Strong teamwork and organizational abilities.
• Awareness of FDA regulations and GMP systems; experience in regulated pharma/biotech facilities.

Responsibilities

• Ensures new equipment is designed/qualified and existing equipment maintained in a compliant manner.
• Performs preventative maintenance activities as equipment owner.
• Coordinates maintenance, calibration and qualification with external vendors.
• Provides engineering, validation and maintenance support to process manufacturing equipment, facilities and utilities.
• Owns and manages small-to-medium changes to process equipment to maintain validated state.
• Investigates deviations and implements corrective actions.
• Participates in FDA/internal audits as SME and responds to observations.
• Monitors equipment performance in line with site reliability strategies.
• Evaluates new technologies and equipment platforms for manufacturing.
• Other related duties as assigned.

Skills

Communication

Technical writing

Teamwork

FDA/GMP familiarity

Education

B.S. in Chemical Engineering

B.S. in Electrical Engineering

B.S. in Mechanical Engineering

Job description

Novartis Gene Therapies 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. The role covers equipment qualification, calibration, deviations, audits, and collaboration with vendors, with growth to more complex processing equipment such as bioreactors and chromatography.

Candidates should have a BS in Chemical, Electrical or Mechanical Engineering and strong