Associate Process Engineer (Cleaning Support Team)

Role Summary

Associate Process Engineer (Cleaning Support Team) at Novo Nordisk in West Lebanon, NH. Focus on cleaning and sterilization of GMP pharmaceutical manufacturing equipment, development and validation of cleaning processes, and support for deviations and change controls. On-floor support across the facility with exposure to Grade C and Grade D clean rooms.

Responsibilities

• Assist with SOPs, JIs, Deviations, and other production documentation for the shopfloor including related problem-solving
• Participate in the development and implementation of procedural or automation improvement changes
• Participate in production-driven improvements to the process and equipment on shopfloor; drive and own minor improvement initiatives and support colleagues
• Develop, write and support documentation needed for production; support trend reports and complex cases owned by the area; present during audits/inspections
• Plan and execute activities according to timeline and ensure timely delivery
• Participate in on-call rotations, including weekends and non-business hours, to provide support
• Perform duties in compliance with healthcare laws, regulations, and industry codes
• Incorporate Novo Nordisk Way and 10 Essentials in all activities
• Other duties as assigned

Qualifications

• Bachelor’s degree in engineering or related discipline required
• Bachelor’s degree with one year of related experience required
• Biotechnology or pharmaceutical experience preferred
• Knowledge of Automation and GMPs requirements preferred
• Excellent communication skills; able to work in a high-paced, team-oriented environment
• Ability to be accessible during on-call periods and respond within 60 minutes

Skills

• Ability to follow routine work instructions for new and ongoing projects
• Strong communication and teamwork

Education

• Bachelor’s degree in engineering or related discipline

Additional Requirements

• On-floor support in Grade C and Grade D clean room production areas; required PPE and GMP adherence
• Physical ability to perform duties in a facility with potential noise and varying environmental conditions; travel 0-10%
• On-call availability including weekends and non-business hours