Commissioning Engineer; Junior - Senior Level

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.

• Leading pay and annual performance bonus for all positions
• 36 paid days off including vacation, sick days & company holidays
• Health insurance, dental insurance, vision insurance
• Guaranteed 8% 401(k) contribution plus individual company match option
• 14 weeks paid parental leave
• Free access to Novo Nordisk‑marketed pharmaceutical products

This position will support commissioning activities by providing analysis, authoring protocols, and commissioning new and existing equipment, processes, and instrumentation in accordance with science and risk‑based validation (SRV). The role will provide input to project team members through all stages of specification setting, supplier selection, and commissioning/qualification/verification. It will help develop requirements, build/construct, design, commission, and perform SAT and FAT verification activities for projects according to SRV and approved timelines.

Work may include commissioning within pharmaceutical manufacturing such as requalification, cleaning, sterilization, and utilities. The role collaborates with production, production support groups, and other stakeholders to ensure completion of deliverables.

The job level and title of the hired candidate will be commensurate with experience. This is an onsite‑based position Monday‑Friday at our bioproduction facility in West Lebanon, NH.

Reports to:

Manager, Technical Support

• Maintains proficiency and understanding of facilities, utilities, systems and equipment operations.
• Author and participate in completing commissioning protocols, execution, data analysis and final report preparation for utilities, equipment and instrumentation, including site acceptance testing (SAT) and factory acceptance testing (FAT).
• Supports consistent and best practices for creating and executing commissioning protocols.
• Ensures accuracy and compliance of commissioning and system records.
• Partners with the Validation Department to provide feedback to the NN validation process group.
• Works and communicates effectively across multiple local departments and international production sites.
• Supports the creation and review of documentation (specifications, SOPs, etc.) in accordance with local, NN and regulatory requirements.
• Supports deviations (DV) and change requests (CR) related to commissioning activities.
• Maintains effective communication and ensures alignment in coordination with appropriate teams.
• Supports facility certification for new or upgraded pharmaceutical manufacturing and quality control facilities as needed and continued operation of such facilities.
• Ensures systems and processes are commissioned in a compliant manner in accordance with FDA, EMA and NN requirements.
• Represents Facilities Engineering and actively participates with cross‑functional teams (validation, manufacturing, engineering, facilities and quality groups) related to commissioning and validation.
• Provides data for assessments associated with change control activities.
• Reviews protocols, summary reports and other documentation associated with commissioning.
• Serves as subject matter expert (SME) for commissioning activities within Facilities Engineering and point of contact with site validation team.
• Maintains technical knowledge and current trends within the commissioning process and SRV programs.
• Supports commissioning concepts, data and approaches for audits and inspections.
• May be required to work in cleanroom/sterile areas, requiring appropriate attire and GMP adherence.
• 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.

• Associate’s degree in life science or…