Associate Process Engineer (Cleaning Support Team)

Role Summary

A process engineer on the cleaning team who specializes in the cleaning and sterilization of GMP pharmaceutical manufacturing equipment in line with Novo Nordisk and FDA requirements. Responsibilities include development and validation of cleaning processes, monitoring during routine use, troubleshooting deviations, and implementing changes to cleaning processes. This role supports cleaning of equipment across the facility and provides on-floor support, documentation, and training to ensure operations run according to cGMP requirements.

Responsibilities

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

Qualifications

• Education and Certifications: Bachelor's degree in engineering or related discipline required
• Work Experience: Bachelor's degree with one year of related experience required; biotechnology or pharmaceutical experience preferred
• Knowledge, Skills, and Abilities: Ability to follow routine work instructions; knowledge of automation and GMPs preferred; excellent communication and teamwork; on-call availability with rapid response

Skills

• Strong communication and teamwork
• GMP and regulatory awareness
• Problem-solving and documentation skills

Education

• Bachelor’s degree in engineering or related discipline

Additional Requirements

• Physical requirements: ability to climb, stoop, kneel, crouch, stand, walk; lift up to 33 lbs occasionally and up to 30 lbs frequently; appropriate use of PPE in cleanroom environments
• Travel: 0-10% Local and International Travel may be required