Validation Engineer I

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 work on validation activities where in-depth analysis, authoring protocols, teamwork and flexibility are required. The person in this role will also be responsible for validation activities in several areas of pharmaceutical manufacturing including, but not limited to, DQ, IQ, OQ, PQ, requalification, cleaning, sterilization and utilities.

Essential Functions

• Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation
• Maintain effective communication and ensure alignment in coordination with appropriate teams
• Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities
• Ensures systems and processes are validated in a compliant manner in accordance with FDA, EU and NN requirements
• Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations
• Completes accurate and timely assessments associated with change control activities
• Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations
• Support validation of new and existing equipment, processes and instrumentation as needed
• Write and review protocols, summary reports and other documentation associated with validations
• Coordinate Validation activities within Novo Nordisk US Bio Production, Inc. as well as with outside vendors as needed
• Represent the Validation department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups)
• Assist in the training of and/or direct the efforts of less experienced Validation Engineers and Validation Technicians
• 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

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%.

Qualifications

• Education and Certifications:
  • Bachelor’s degree or equivalent experience in life sciences or engineering
• Work Experience:
  • A minimum of three (3) years validation experience in the pharmaceutical or biotechnology industry
  • Experience preparing protocols, executing data analysis, and report writing
  • Experience preparing protocols, executing data analysis, and report writing

• Knowledge, Skills, and Abilities:
  • Ability to demonstrate broad understanding of:
    • Concepts of Validation
    • Change control processes
    • Root cause analysis techniques and cGMP documentation practices
    • cGMP regulations, GMP and other industry standards pertaining to validation
    • Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation
    • Excellent written and verbal communication skills a must
    • A strong work ethic (self-motivated) and demonstrated ability to work in teams

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.