Commissioning Engineer (Associate - Level II)

Role: Facilities Engineer specializing in commissioning within Novo Nordisk's biopharmaceutical manufacturing facility. Primary objectives include supporting equipment and process commissioning, validation, and qualification activities aligned with science and risk-based validation (SRV) standards. Responsibilities encompass authoring and executing commissioning protocols, analyzing data, and preparing final reports for utilities, equipment, and instrumentation, including site and factory acceptance tests (SAT/FAT). The role involves ensuring compliance with GMP, FDA, EMA, and internal standards, supporting facility certification, and collaborating across functions such as Validation, Manufacturing, and Quality. Qualifications: Associate's degree in life science or engineering with 2+ years of relevant experience; a Bachelor's degree is preferred. Experience with data analysis, report writing, validation concepts, change control, and cGMP regulations is desirable. Skills include effective communication, teamwork, and the ability to work independently. High-value specifics: Onsite position at West Lebanon, NH, with 0-10% travel; experience in pharmaceutical or biotech manufacturing preferred, particularly in GMP environments. The role emphasizes maintenance of technical knowledge in commissioning and validation processes, supporting audits and inspections, and ensuring system compliance from commissioning through ongoing operation.