Process Engineer Level I-II (Downstream)

Novo Nordisk•West Lebanon, NH

55d•Onsite

About The Position

This role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative mainteanance and equipment repairs are carried out correctly. May be responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process Associates and Process Scientists and may support day to day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role. The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.

Requirements

Bachelor's degree in engineering or related discipline required
Bachelor's degree with three (3) years related experience required
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, nighttime, and weekend on call support as needed

Nice To Haves

Medium to large scale pharmaceutical or biotechnology process experience preferred
Knowledge of Automation and GMPs requirements preferred
Broad understanding of science and risk-based verification (I.E. ASTM E2500)
Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred
Knowledge of good engineering practices

Responsibilities

Assist with SOPs, JIs, DVs and other production documentation to the shopfloor
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 an own minor improvement initiatives and support colleagues
Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
Maintain effective communication and ensure alignment in coordination with appropriate teams
Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations
Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations
Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed
Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
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