Posted to MedZilla on 1/13/2018


Novo Nordisk

US-NH, Validation Engineer Job 437364900A2-MZ


 
 

Requisition ID 51128BR
Title Validation Engineer
Job Category Quality
Job Description 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:
Education:
* Bachelors degree or equivalent experience in life sciences or engineering
Experience:
* 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%

Department NNUSBPI - MFG ENG & VALIDATION (2)
Position Location US - Lebanon, NH
City West Lebanon
State/Provinces US - NH
Job/Position Country US

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: https://www.surveymonkey.com/r/novoaccommodation. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.


Please visit our website at www.novonordisk.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.