Associate Process Engineer (Cleaning Support Team)

Novo Nordisk•West Lebanon, NH

48d•Onsite

About The Position

A process engineer on the cleaning team is a process engineer who specializes in the cleaning and sterilization of GMP pharmaceutical manufacturing equipment in line with Novo Nordisk and FDA requirements. They are responsible for the development of cleaning processes, the validation of those processes, and for monitoring those processes during routine use. As specialists in the cleaning process, they support troubleshooting cleaning failures (deviations) and making changes to cleaning processes (change controls). This role will support the cleaning of equipment throughout our whole facility and it is a great opportunity for someone interested in getting exposure to a wide range of equipment and systems used throughout the biopharmaceutical manufacturing process. Responsible for supporting cleaning and sterilization of equipment through on-floor knowledge and support, documentation to keep processes running efficiently, and supporting training of cleaning processes to run according to cGMP requirements. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH. This role will require on-floor support in our Grade C and Grade D clean room production areas. Working in the cleanroom areas may require wearing: hairnet, beard cover, frocks/coveralls, shoe covers, snood, face mask, sterile gloves, and to follow GMP processes at all times. Examples of prohibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelery, cosmetics, nail acrylics, perfume/cologne, and personal cell phones.

Requirements

Bachelor's degree in engineering or related discipline required
Bachelor's degree with one (1) year of related experience required
Ability to follow routine work instructions for new and ongoing projects and assignments
Excellent communication skills and ability to work in a high-paced team-oriented environment
Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes

Nice To Haves

Biotechnology or pharmaceutical experience preferred
Knowledge of Automation and GMPs requirements preferred

Responsibilities

Assist with SOPs, JIs, Deviations,cand 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 any documentation needed for production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
Plan and execute according to timeline and ensure timely delivery of own activities
Participate in on-call rotations, including weekends and non-business hours, to provide support
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
Other duties as assigned