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Associate Commissioning Engineer

Employer
Novo Nordisk
Location
West Lebanon, NH
Start date
Aug 8, 2024
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Job Details

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
  • 12 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.

 

This position can be considered for Commissioning Engineer Levels: Associate Engineer, and/or levels I-III dependent on candidate meeting minimum qualifications for such roles.

 

Relationships

Reports to: Sr. Manager - Facilities Engineering & Metrology

 

Number of subordinates with direct/indirect referral: None

 

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:
  • One (1) year related experience with bachelor’s degree preferred
  • Two (2) years related experience with an Associates required
  • 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 analyzing; 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: odors, 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 recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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