Commissioning Engineer (Associate - Level II)

BioSpace; West Lebanon (NH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive pay + annual bonus

36 paid days off

Health, dental, vision insurance

8% 401K match

Paid parental leave

Product access

Job summary

Novo Nordisk is seeking a Facilities Engineering specialist at the West Lebanon, NH bioproduction site. The role focuses on commissioning activities, SRV-driven validation, and collaboration with production, validation, and quality teams to ensure compliant protocols and successful project delivery.

The position emphasizes experience in GMP environments, data analysis, and documentation, with opportunities for career growth and mentorship within NN’s global manufacturing network.

Qualifications

• Associate degree with two years of related experience required.
• Bachelor's degree with one year related experience preferred.
• Pharmaceutical process or biotechnology experience preferred.
• Knowledge of data analysis and cGMP documentation practices.

Responsibilities

• Author and participate in commissioning protocols and execution for utilities, equipment and instrumentation.
• Support development of SRV-based validation activities and site acceptance/testing where applicable.
• Ensure compliance of commissioning records and documentation with FDA, EMA, and NN requirements.
• Collaborate with cross-functional teams (Validation, Manufacturing, Engineering, Facilities and Quality).
• Provide SME input and data for change controls and protocol reviews.

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

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.

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 positions
• 36 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 14 weeks Paid Parental Leave
• Free 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 operations
• Author 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 protocols
• Ensures accuracy and compliance of commissioning and system records
• Partner with the Validation Department to participate and provide feedback to NN validation process group
• Ability to work and communicate effectively across multiple local departments. multiple international production sites
• Support 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
• Maintain effective communication and ensure alignment in coordination with appropriate teams
• Support 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 facilities
• Ensures systems and processes are commissioned in a compliant manner in accordance with FDA, EMA and NN requirements
• Represent Facilities Engineering and actively participate with cross-functional teams (Validation, Manufacturing, Engineering, Facilities and Quality groups) related to commissioning and validation
• Provide data for assessments associated with change control activities
• Review 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 science and risk-based validation (SRV) programs
• Support commissioning concepts, data and approaches for audits and inspections
• 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

Qualifications

• Education and Certifications: Associate's degree in life science or engineering required
• Bachelor's degree in life science or engineering preferred
• Work Experience: Associate’s degree with two (2) years of related experience required
• Bachelor’s degree with one (1) year related experience preferred
• Pharmaceutical process or biotechnology experience preferred
• Knowledge, Skills and Abilities: Experience with data analysis and report writing
• Entry level understanding of:
• Concepts of Validation and commissioning
• Change control processes
• Root cause analysis techniques and cGMP documentation practices preferred, not required can be learned on the job
• cGMP regulations preferred
• Excellent written and verbal communication skills a must
• A 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.

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.