GMP Process Engineer I - Validation & Maintenance

U473 (FCRS = US473) Novartis Gene Therapies; North Carolina; On-site; USD 41,000 - 76,000; Full time

Job summary

Novartis Gene Therapies in North Carolina seeks a Process Engineer I or II to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities, and utilities at the site. You will manage equipment lifecycle, coordinate with vendors, and assist in audits and investigations.

The role requires a BS in chemical/electrical/mechanical engineering (or related field) with experience in regulated biopharma environments, strong communication and problem-solving

Qualifications

• B.S. degree in Chemical, electrical or mechanical engineering or related technical field.
• Experience in GMP biopharmaceutical manufacturing is preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Ensure new equipment is designed/qualified and maintained in a compliant state throughout lifecycle.
• Execute administrative preventive maintenance activities as equipment owner.
• Facilitate equipment maintenance, calibration, and qualification with external vendors.
• Provide engineering, validation and maintenance support to process manufacturing, facilities and utilities at the site.
• Equipment will include bench-top instruments, biosafety cabinets, incubators and freezers; back-up for major processing equipment.
• Own and manage small to medium changes to process equipment to maintain a validated state.
• Investigate equipment or process deviations and develop corrective actions to prevent recurrences.
• Participate in FDA and internal audits as SME and respond to observations.
• Monitor equipment performance in line with site reliability and maintenance strategies.
• Apply engineering principles to ensure robust solutions and evaluate new technologies.

Skills

Communication skills

Technical writing

Team player

FDA regulations awareness

Education

B.S. in Chemical, Electrical or Mechanical Engineering

Job description

Novartis Gene Therapies in North Carolina seeks a Process Engineer I or II to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities, and utilities at the site. You will manage equipment lifecycle, coordinate with vendors, and assist in audits and investigations.

The role requires a BS in chemical/electrical/mechanical engineering (or related field) with experience in regulated biopharma environments, strong communication and problem-solving