Requisition ID 42920BR<br/>Title Validation Engineer<br/>Job Category Engineering<br/>Job Description<br/>We have an exciting new opportunity to join our growing team as a Validation Engineer! This position will support validation activities providing analysis, authoring protocols, and validating new and existing equipment, processes and instrumentation. This role will perform validation activities in several areas of pharmaceutical manufacturing such as: DQ, IQ, OQ, PQ, requalification, cleaning, sterilization and utilities.<br/><br/>Relationships:<br/><br/>* Reports to: Validation Project Manager III<br/>* Will receive direction and support from Validation Project Manager.<br/>* Works closely with manufacturing groups, engineering, facilities, quality & MSAT.<br/>* No direct reports.<br/><br/>Main Job Tasks:<br/><br/>* Complete validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation.<br/>* Maintain effective communication and ensure alignment in coordination with appropriate teams.<br/>* 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.<br/>* Ensures systems and processes are validated in a compliant manner in accordance with FDA, EU and NN requirements.<br/>* Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.<br/>* Provide data for assessments associated with change control activities.<br/>* Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations.<br/>* Participate in the validation of new and existing equipment, processes and instrumentation as needed.<br/>* Review protocols, summary reports and other documentation associated with validations.<br/>* Represent the Validation department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups).<br/>* Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.<br/><br/>* Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.<br/><br/>Physical Requirements:<br/><br/>* Ability to lift up to 40 lbs. with assistance.<br/>* Ability to work in confined spaces and near operating equipment.<br/>* Ability to be clean room certified.<br/><br/>* Ability to accommodate extensive international travel.<br/>* Ability to work in loud noise environments.<br/>* Ability to work hours necessary to support project, 24/7 production and /or maintenance activities.<br/>* Travel:<br/><br/>Knowledge, Skills and Experience:<br/><br/>* Bachelors degree or equivalent experience in life sciences or engineering.<br/>* One (1) year of related experience, preferred.<br/>* Experience with data analysis and report writing.<br/>* Entry level understanding of:<br/>* Concepts of Validation;<br/>* Change control processes;<br/>* Root cause analysis techniques and cGMP documentation practices;<br/>* cGMP regulations.<br/><br/>* Excellent written and verbal communication skills a must.<br/>* A strong work ethic (self-motivated) and demonstrated ability to work in teams.<br/><br/>Department NNUSBPI - MFG ENGINEERING & VALIDATION<br/>Position Location US - Lebanon, NH<br/>City West Lebanon<br/>State/Provinces US - NH
<br/><br/>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
<br/><br/>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!
<br/><br/><p class="eeo_desc">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.<br/><br/>
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.<br/><br/>
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