Validation Engineer I Position Available In Grafton, New Hampshire

Job Description:

About the Department Site New Hampshire, located in WestLebanon, is where Novo Nordisk’s life-saving treatments are broughtto life. Our manufacturing facility produces a global supply of ourhemophilia and growth hormone product lines, as well as our nextgeneration of cutting-edge medications.

What we offer you:

Leadingpay and annual performance bonus for all positions 36 Paid days offincluding vacation, sick days & company holidays Health Insurance,Dental Insurance, Vision Insurance Guaranteed 8% 401K contributionplus individual company match option 14 weeks Paid Parental LeaveFree access to Novo Nordisk-marketed pharmaceutical products AtNovo Nordisk, you will find opportunities, resources and mentorshipto grow and build your career. Are you ready to realize yourpotential? The Position The person in this role will also beresponsible for validation activities in several areas ofpharmaceutical manufacturing including, but not limited to, DQ, IQ,OQ, PQ, requalifications, cleaning, sterilization and utilities.

This position will support the day to day execution of validationactivities, and related documentation/technical writing overseen bysupport of more senior Validation Engineers. This is an onsitebased role Monday-Friday at our West Lebanon, NH bio-productionfacility. Relocation assistance may be available for elgibilecandidates.

Relationships Reports to:

Lead Engineer, Validation(Supervisor) Essential Functions Primary responsibilities includevalidation protocol execution (IQ, OQ, PQ & PV), data analysis andfinal report preparation for utilities, equipment andinstrumentation Maintain effective communication and ensurealignment in coordination with appropriate teams Support facilitycertification for new Manufacturing (process equipment &facility-support equipment) and Quality Control facilities asneeded as well as the continued operation of such facilitiesEnsures systems and processes are validated in a compliant mannerin accordance with FDA, EU and NN requirements Actively participateon cross functional teams to determine the root cause andcorrective actions for problems associated with investigationsCompletes accurate and timely assessments associated with changecontrol activities Ensures change control activities for systemsare completed in a manner in compliance with FDA, EU and NNregulations Support validation of new and existing equipment,processes and instrumentation as needed Write and review protocols,summary reports and other documentation associated with validationsCoordinate Validation activities within Novo Nordisk US BioProduction, Inc. as well as with outside vendors as neededRepresent 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 lessexperienced Validation Engineers and Validation TechniciansPerforms all job duties and responsibilities in a compliant andethical manner and in accordance with all applicable healthcarelaws, regulations and industry codes Incorporates the Novo NordiskWay and 10 Essentials in all activities and interactions withothers Qualifications Education and Certifications Bachelor’sdegree or equivalent experience in life sciences or engineeringWork Experience A minimum of three (3) years validation experiencein the pharmaceutical or biotechnology industry Experiencepreparing protocols, executing data analysis, and report writingExperience preparing protocols, executing data analysis, and reportwriting Knowledge, Skills, and Abilities Ability to demonstratebroad understanding of Concepts of Validation Change controlprocesses Root cause analysis techniques and cGMP documentationpractices cGMP regulations, GMP and other industry standardspertaining to validation Technical requirements for Validation andof biopharmaceutical equipment, facilities and/or instrumentationExcellent written and verbal communication skills a must A strongwork ethic (self-motivated) and demonstrated ability to work inteams 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, andunderstand verbal and written communication. Repetition includingsubstantial movement of wrists, hands, and or fingers. Lifting upto 33lbs/15kg of force occasionally, and/or up to 30 pounds offorce frequently, and/or up to 10 pounds of force constantly tomove objects. Visual acuity to perform close activities such as:reading, writing, and analysing; and visual inspection. The workingenvironment includes a variety of physical conditions includingnoise, inside and outside conditions, working in narrow aisles, andtemperature changes; atmospheric conditions including: odors,fumes, and dust.

Local and International Travel:

0-10%. We committo an inclusive recruitment process and equality of opportunity forall our job applicants. At Novo Nordisk we recognize that it is nolonger 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 knowthat this is only possible with talented employees with diverseperspectives, backgrounds and cultures. We are therefore committedto creating an inclusive culture that celebrates the diversity ofour employees, the patients we serve and communities we operate in.

Together, we’re life changing. Novo Nordisk is an equal opportunityemployer. Qualified applicants will receive consideration foremployment without regard to race, ethnicity, color, religion, sex,gender identity, sexual orientation, national origin, disability,protected veteran status or any other characteristic protected bylocal, state or federal laws, rules or regulations. If you areinterested in applying to Novo Nordisk and need special assistanceor an accommodation to apply, please call us at 1-855-411-5290.This contact is for accommodation requests only and cannot be usedto inquire about the status of applications.