Commissioning Engineer; Junior - Senior Level

About the Department

Site New Hampshire, located in West Lebanon, brings Novo Nordisk’s life‑saving treatments to life. The manufacturing facility produces a global supply of hemophilia and growth hormone product lines and next generation cutting‑edge medications.

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

This onsite position (Monday‑Friday) at our bioproduction facility in West Lebanon, NH, supports 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).

Responsibilities include:

• Providing input to project teams during all stages of specification setting, supplier selection and commissioning/qualification/verification.
• Developing requirements, building, constructing, designing, commissioning and performing SAT and FAT verification activities for projects according to SRV and approved timelines.
• Performing commissioning within pharmaceutical manufacturing, such as requalification, cleaning, sterilization and utilities.
• Collaborating with production, production support groups and other stakeholders to ensure completion of deliverables.

Job level and title will be commensurate with experience.

Reports to:

Manager, Technical Support

Maintains proficiency in 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.
• Support consistent best practices for creating and executing commissioning protocols.
• Ensure accuracy and compliance of commissioning and system records.
• Provide feedback to the Validation Department and participate in the NN validation process group.
• Work and communicate effectively across multiple local and international production sites.
• Support the creation and review of documentation (specifications, SOPs, etc.) in accordance with local, NN and regulatory requirements.
• Support deviations (DV) and change requests (CR) related to commissioning activities.
• Maintain effective communication and coordination with appropriate teams.
• Support facility certification for new or upgraded pharmaceutical manufacturing and quality control facilities.
• Ensure compliance with FDA, EMA and NN requirements.
• Serve as subject‑matter expert for commissioning activities and be the point of contact with the site Validation Team.
• Maintain technical knowledge of commissioning processes and SRV programs.
• Support commissioning concepts, data and approaches for audits and inspections.

This role may require working in cleanroom/sterile areas, following GMP processes and wearing appropriate protective gear.

Perform all duties in a compliant and ethical manner in accordance with applicable healthcare laws, regulations and industry codes.

Adopt Novo Nordisk Way and core values in all activities and interactions.

• Associate’s degree in life science or engineering required.
• Bachelor’s degree in life science or engineering preferred.
• Associate’s degree with two years of related experience required.
• Bachelor’s degree with one year of related experience preferred.
• Experience with data analysis and report writing.
• Entry‑level understanding of validation and commissioning concepts, change control processes and root‑cause analysis.
• Knowledge of cGMP documentation practices preferred.
• Excellent written and verbal communication skills.
• Strong work ethic and ability to work independently or in teams.

Ability to climb, stoop, kneel, crouch, crawl, reach, stand, and walk. Ability to push, pull, lift up to 33 lbs (15 kg) occasionally, up to 30 lbs frequently, and up to 10 lbs constantly. Ability to speak, listen, and understand verbal and written communication. Repetition of wrist, hand or finger movements. Visual acuity for close tasks. Work environment includes noise, temperature changes, fumes, dust.

Local and international travel 0‑10%.

We commit to an inclusive recruitment process and equality of opportunity for all applicants.

We are an equal‑opportunity employer. Qualified applicants will receive consideration without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability or protected veteran status.

If you need special assistance or accommodation to apply, please call 1‑855‑411‑5290. This contact is for accommodation requests only and cannot be used to inquire about application status.