Commissioning Engineer (Associate - Level II)

Initial Therapeutics, Inc.; West Lebanon (NH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Paid time off

401K with company match

Parental Leave

Job summary

Novo Nordisk in West Lebanon, NH, is seeking a Facilities/Project Engineer to support commissioning activities for equipment, processes, and instrumentation in a GMP environment. You will contribute to protocol development, selection of suppliers, and SAT/FAT verification, ensuring timely deliverables and regulatory compliance.

The role requires an associate or bachelor degree in life science or engineering, with 1–2 years of related experience preferred; strong data analysis and communication

Qualifications

• Experience with data analysis and report writing.
• Entry level understanding of: Validation and commissioning concepts.
• Root cause analysis techniques and cGMP documentation practices preferred, not required.

Responsibilities

• Author and participate to complete commissioning protocols and execution.
• Data analysis and final report preparation for utilities, equipment and instrumentation.
• Support deviations and change requests related to commissioning activities.
• Coordinate with cross-functional teams to ensure compliant commissioning and validation.

Skills

Data analysis

Report writing

Communication skills

Team collaboration

Education

Associate's degree in life science or engineering

Bachelor's degree in life science or engineering

Tools

Validation procedures

Change control processes

Job description

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.

What we offer you:

• Leading pay and annual performance bonus for all positions36Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option14weeks Paid Parental LeaveFree access to Novo Nordisk-marketed pharmaceutical products

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

This position will support commissioning activities providing analysis, authoring protocols and commissioning new and existing equipment, processes and instrumentation in accordance with science and risk-based validation (SRV). This role will provide input to project team members through all stages of specification setting, supplier selection and commissioning / qualification /verification. This role will also help develop requirements, build/construct, design, commission, perform SAT and FAT verification activities for projects according to (SRV) and approved timelines. This work may include commissioning within pharmaceutical manufacturing such as: requalification, cleaning, sterilization and utilities. Collaboration with production, production support groups and other stakeholders to ensure completion of deliverables. Prior experience in a GMP or Life Science environment is preferred.

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.

Relationships

Reports to: Sr. Manager, Project Engineering

Essential Functions

• Maintains proficiency and understanding of Facilities, Utilities, Systems and equipment operationsAuthor and participate to complete commissioning protocols and execution, data analysis and final report preparation for utilities, equipment and instrumentation. This may include site acceptance testing (SAT) and factory acceptance testing (FAT)Supports consistent and best practices for creating and executing commissioning protocolsEnsures accuracy and compliance of commissioning and system recordsPartner with the Validation Department to participate and provide feedback to NN validation process groupAbility to work and communicate effectively across multiple local departments. multiple international production sitesSupport the creation and review of documentation (Specifications, SOPs, etc.) in accordance with local, NN and regulatory requirementsSupports Deviations (DV) and Change requests (CR) related to commissioning activitiesMaintain effective communication and ensure alignment in coordination with appropriate teamsSupport facility certification for new or upgraded Pharmaceutical Manufacturing (process equipment and facility-support equipment) and Quality Control facilities as needed and the continued operation of such facilitiesEnsures systems and processes are commissioned in a compliant manner in accordance with FDA, EMA and NN requirementsRepresent Facilities Engineering and actively participate with cross-functional teams (Validation, Manufacturing, Engineering, Facilities and Quality groups) related to commissioning and validationProvide data for assessments associated with change control activitiesReview protocols, summary reports and other documentation associated with commissioningServes as Subject Matter Expert (SME) for commissioning activities within Facilities Engineering and point of contact with site Validation TeamMaintains technical knowledge and current trends within the commissioning process and science and risk-based validation (SRV) programsSupport commissioning concepts, data and approaches for audits and inspectionsPerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersOther duties as assigned

Qualifications

• Education and Certifications:Associate's degree in life science or engineering requiredBachelor's degree in life science or engineering preferred

Work Experience:Associate’s degree with two (2) years of related experience requiredBachelor’s degree with one (1) year related experience preferredPharmaceutical process or biotechnology experience preferredKnowledge, Skills and Abilities:Experience with data analysis and report writingEntry level understanding of:Concepts of Validation and commissioningChange control processesRoot cause analysis techniques and cGMP documentation practices preferred, not required can be learned on the jobcGMP regulations preferredExcellent written and verbal communication skills a mustA strong work ethic (self-motivated) and demonstrated ability to work in teams as well as independently

Physical Requirements

The ability to climb. stoop, kneel, crouch, crawl, reach, stand and walk. The ability to push, pull, lift, finger, feel and grasp. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 33lbs/15kg of force occasionally and/or up to 30 pounds of force frequently and/or up to 10 pounds of force constantly to move objects. Visual acuity to perform close activities such as: reading, writing and analysing; and visual inspection. The working environment includes a variety of physical conditions including: noise, inside and outside conditions, working in narrow aisles and temperature changes; atmospheric conditions including: odours, fumes and dust. Local and International Travel: 0-10%.

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.