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. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. 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

Act as a validation Subject Matter Expert (SME), ensuring a science and risk-based validation approach on defining strategy for projects. Have organizational influence as a Validation Specialist in setting direction for validation at Site New Hampshire. Champion for ensuring that the validated state of the facility, utilities, systems, and equipment are maintained.

Relationships

Reports to: according to the organization chart.

Direct reports: none

Essential Functions

• Set validation strategy for projects of small and medium scale complexity
• Ensure validation strategy is met for projects of large-scale complexity
• Author validation plans and review/approve validation documents to ensure that requirements are met
• Ensure adherence to quality and regulatory requirements for validation of facilities, utilities, computerized equipment, laboratory equipment, cleaning and/or process, as required
• Present validation documents and strategy in internal audits and external inspections
• Maintain regulatory documentation as it relates to changes in the validated state
• Manage revalidations, system evaluations, and continued process verification schedules
• Lead contract teams to deliver validation projects, as required
• Independently analyzes and interprets data with limited consultation with supervisor, makes independent tactical decisions based on data, develops project strategies with consultation with supervisor
• Provide technical mentorship and peer leadership to personnel performing validation activities
• Represent Validation on cross-functional teams
• Limited supervision for day-to-day activities; meets regularly with supervisor to update on progress towards long-term goals
• 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

Physical Requirements

Local and International Travel: 0-10%. 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. Visual acuity to perform close activities such as: reading, writing, and analyzing. 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.

Qualifications

• Education and Certifications
  • Requires a Bachelor’s degree in an Engineering or Science discipline
• Work Experience
  • Five (5) years of related experience required

• Knowledge, Skills, and Abilities
  • A strong understanding of GEP and Validation concepts, international cGMP regulations, and industry standards pertaining to the technical and verification requirements for facilities, utilities, systems and equipment
  • A strong work ethic (self-motivated), honesty, excellent communication skills, and the ability to work in teams - displays initiative and commitment

This position is located in West Lebanon, New Hampshire and will require onsite work. It is a full time (40 hours per week) position and the standard schedule is Monday-Friday 8am to 5pm, with on-call as needed.

We offer a competitive salary, commensurate with experience. Relocation assistance provided.

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.