Requisition ID 42734BR<br/>Title Validation Manager<br/>Job Category Validation<br/>Job Description<br/>Novo Nordisk New Hampshire has an exciting new opportunity to join our team as a Validation Manager. The person in this role will lead the facility, utility, equipment and system & cleaning validation activities for the site and manage validation projects as required. The position is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.<br/><br/>This person will also work with the Senior Manager, Manufacturing Engineering, Automation and Validation to manage and create group strategy and systems, allocating resources to projects, managing timelines for projects, departmental budget and developing the talent within the department.<br/><br/>Relationships:<br/><br/>Reports to: Senior Manager, Manufacturing Engineering, Automation and Validation.<br/><br/>Main Job Tasks:<br/><br/>* Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements and independently contributes to the development of new validation standards<br/>* System owner for process equipment qualification, laboratory instrument qualification, facility/utility qualification, control system qualification, and associated systems and procedures<br/>* Contribute to long-term strategic development of validation projects<br/>* Organizes and presents (either written or verbally) their work with limited supervisor help.<br/>* Independently analyzes and interprets validation data with limited consultation with supervisor, makes independent tactical decisions based on data, develops project strategies with consultation with supervisor.<br/>* Contributes Validation input and represents the Validation function on cross-functional teams.<br/>* Independently initiates, designs, and evaluates plans for site projects, completely responsible for planning and execution of all tasks needed to meet goals. Establishes priorities and begins to consider long range project planning with consultation with supervisor, good project and personnel management skills are required.<br/>* No supervision for day-to-day activities required, meets regularly with supervisor to update on progress towards long-term goals.<br/>* Leads the preparation and execution of validation protocols, data analysis and final reporting.<br/>* Manages annual revalidation schedules for assigned sites.<br/>* Manage compliance of validation activities with other departments to meet established validation policies and procedures, cGMP requirements, and industry standards.<br/>* Contributes and works on Validation activities for other sites other than the assigned sites as needed.<br/>* Lead for all validation discussions during health authority inspections. Provides validation overview, annual assessments and specific project to auditors.<br/>* Responsible for all validation audit responses.<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/>· Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.<br/><br/>Physical Requirements:<br/><br/>Travel: 10%.<br/>Development of People:<br/>* This position will have up to five direct reports. Supervisory responsibilities will include:<br/>* Managing employees to assure they are able to meet project goals, schedules and budgets.<br/>* Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.<br/>* Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.<br/>* Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.<br/><br/>Knowledge, Skills and Experience:<br/><br/>* Bachelor’s degree or equivalent experience in life sciences or engineering with 10 plus years validation experience in the pharmaceutical or biotechnology industry, or a Master’s degree or equivalent experience in life sciences or engineering with a minimum of six (6) years validation experience in the pharmaceutical or biotechnology industry, preferably eight (8) years.<br/>* A successful history of managing validation department is required, with experience in health authority audits.<br/>* A strong understanding of: Validation concepts, international cGMP regulations, GAMP and other industry standards pertaining to validation, and the technical requirements for Validation and of biopharmaceutical equipment, facilities, and/or instrumentation.<br/>* A strong work ethic (self-motivated) honesty, excellent communication skills, and the ability to work in teams-displays initiative and commitment.<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/>
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: <a href="https://www.surveymonkey.com/r/novoaccommodation" target="_blank" title="Accomodation Survey">https://www.surveymonkey.com/r/novoaccommodation</a>. 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.</p>
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