Validation Engineer Job:
Novo Nordisk

Novo Nordisk
West Lebanon New Hampshire
Novo Nordisk US Bio Production, Inc. has an immediate opening for an experienced Validation Engineer to join our team! 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.

Main job tasks:
  • 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.

Knowledge, skills & abilities and experience:
  • Bachelors degree or equivalent experience in life sciences or engineering
  • A minimum of three (3) years validation experience in the pharmaceutical or biotechnology industry
  • Experience preparing protocols, executing data analysis, and report writing
Skills & abilities:
  • Experience preparing protocols, executing data analysis, and report writing
  • 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
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 35 pounds 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%

Requisition ID: 51128BR
State/Provinces: West Lebanon
Job Category: Quality

Basic Qualifications