Process Engineer I - GMP Equipment Maintenance

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

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 includes ensuring equipment design qualification, coordinating calibration with vendors and maintaining a validated state.

Ideal candidates have a BS in Chemical, Electrical or Mechanical Engineering with related GMP experience, plus strong communication and technical writing skills.

Qualifications

• BS degree with < 2 years of relevant GMP pharma experience (Engineer I) or > 2 years (Engineer II).
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Team environment experience with good organizational skills.
• Awareness of FDA regulations and GMP systems.

Responsibilities

• Ensure new equipment is designed/qualified and existing equipment is maintained in a compliant state.
• Perform preventative maintenance activities as equipment owner.
• Coordinate maintenance, calibration, and qualification with vendors.
• Support process manufacturing equipment, facilities and utilities at the site.
• Maintain validated state during changes and investigate deviations.
• Contribute to audits as SME and support site reliability strategies.
• Evaluate new technologies and equipment platforms for manufacturing.

Skills

Communication

Technical writing

Team collaboration

Regulatory awareness

Problem solving

Education

BS in Chemical/Electrical/Mechanical Eng

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 includes ensuring equipment design qualification, coordinating calibration with vendors and maintaining a validated state.

Ideal candidates have a BS in Chemical, Electrical or Mechanical Engineering with related GMP experience, plus strong communication and technical writing skills.