Junior Process Engineer – GMP Manufacturing & Validation

Biopharma Careers; North Carolina; On-site; USD 41,000 - 76,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis seeks a Process Engineer I or II for its North Carolina site to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities and utilities. The role involves ensuring equipment is designed/qualified, managing maintenance, and coordinating calibration with external vendors.

The candidate should have a B.S. in Chemical, Electrical or Mechanical Engineering with 2 years of GMP pharma experience (or 6 years equivalent) and possess excellent

Qualifications

• B.S. degree in Chemical, Electrical or Mechanical Engineering or related field, with 2 years GMP pharma experience or 6 years equivalent.
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Experience in a regulated pharma/biotech facility and FDA awareness.

Responsibilities

• Ensure new equipment is designed/qualified and existing equipment maintained in a compliant state.
• Perform preventative maintenance activities as equipment owner.
• Coordinate calibration and qualification with external vendors.
• Provide engineering, validation and maintenance support for process equipment and utilities.
• Support equipment such as benchtop instruments, biosafety cabinets, incubators and freezers; assist with major processing equipment.
• Investigate deviations and implement corrective actions to prevent recurrence.
• Participate in FDA and internal audits as SME and respond to observations.
• Monitor equipment performance per site reliability strategies.
• Apply engineering principles to ensure robust solutions and evaluate new technologies for manufacturing.
• Other related duties as assigned.

Skills

Communication skills

Technical writing

Team collaboration

Education

B.S. degree in Chemical, Electrical or Mechanical Engineering

Job description

Novartis seeks a Process Engineer I or II for its North Carolina site to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities and utilities. The role involves ensuring equipment is designed/qualified, managing maintenance, and coordinating calibration with external vendors.

The candidate should have a B.S. in Chemical, Electrical or Mechanical Engineering with 2 years of GMP pharma experience (or 6 years equivalent) and possess excellent