About the Department
Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?
Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale.
Main Job Tasks
- Assist with coordinating fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems. Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparation
- Participate in the development and implementation of procedural or automation improvement changes
- Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact or user representative for contractor services including design, fabrication, installation and verification
- Support person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
- Maintain effective communication and ensure alignment in coordination with appropriate teams
- Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities
- Ensures systems and processes are validated in a compliant manner in accordance with Food & Drug Administration (FDA), EU and NN requirements
- Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations
- Completes accurate and timely assessments associated with change control activities
- Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations
- Support verification of new and existing equipment, processes and instrumentation as needed
- Write and review protocols, summary reports and other documentation associated with validations
- Coordinate verification activities within Novo Nordisk US Bio Production, Inc. as well as with outside vendors as needed
- Represent the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups)
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
Knowledge, Skills & abilities and Experience
Requires a bachelor’s degree in engineering or related discipline.
A minimum of two (2) years related experience. Prefer medium to large scale pharmaceutical or biotechnology process experience.
Skills & Abilities
- Ability to follow routine work instructions for new and ongoing projects and assignments
- Knowledge of Automation and GMPs requirements preferred
- Broad understanding of science and risk-based verification (I.E. ASTM E2500)
- Knowledge of good engineering practices
- Excellent written and verbal communication skills a must
- Excellent communication skills and ability to work in a high-paced team-oriented environment
- Ability to provide evening, night time, and weekend on call support as needed
- Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred
Physical Requirements and Working Environment
- The ability to climb. stoop, kneel, crouch, crawl, reach, stand, and walk
- The ability to push, pull, lift, finger, feel, and grasp
- The ability to speak, listen, and understand verbal and written communication
- Repetition including substantial movement of wrists, hands, and or fingers
- Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
- Visual acuity to perform close activities such as: reading, writing, and analyzing; and visual inspection
- The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including: odors, fumes, and dust
- Local and International Travel: 0-10%
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.