Hiring: Process Engineer I Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-10 10:21:06 About the job Experience: •2 years relevant work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 4 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. •2 years relevant work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. Required Skills: •Ensuring new equipment is appropriately designed/qualified and existing equipment is maintained in a compliant manner throughout equipment lifecycle. •Executes administrative preventative maintenance activities as equipment owner. •Facilitates equipment maintenance, calibration, and qualification with external vendors. •Owns and manages small to medium changes to process equipment to maintain equipment in a validated state. •Investigating any equipment or process deviations and developing corrective actions to prevent reoccurrences. •Participate in all FDA and internal audits of the manufacturing facilities and equipment as SME and respond to any observations received. •Actively monitor equipment performance in compliance with site reliability and maintenance strategies. Applies knowledge of engineering principles and best practices to ensure robust solutions. •Help evaluate new technologies and equipment platforms for manufacturing. Qualifications: •B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with <2 years relevant work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 4 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. •B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with >2 years relevant work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. •Excellent oral and written communication skills. Strong technical writing ability required. •Working in a team environment, with excellent communication and organizational skills. •Awareness of FDA regulations and GMP systems or experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. •Developing professional expertise, applies company policies and procedures to resolve a variety of issues. •Demonstrated capacity to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. •Exercises judgment within defined procedures and practices to determine appropriate action. •Builds productive internal/external working relationships. •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!