Senior Validation Engineer

About the Department     

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

 

 

What we offer you:

• Leading pay and annual performance bonus for all positions
• 34 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 12 weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

 

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

 

The Position

This position will be responsible for the creation, management and execution of compliance and validation processes for the facility, utility, equipment and system & cleaning activities for the NNUSBPI sites 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. Also, will work with NNUSBPI leadership to manage and create group strategy and systems, allocating resources to projects, managing timelines for qualification projects and developing the talent within the department.

 

Essential Functions

• Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements and independently contributes to the development of the Validation Team and contributes to the development of validation practices
• System owner for equipment qualification, laboratory equipment qualification, facility/utility qualification, control system qualification, and associated systems and procedures
• Contribute to long-term strategic development of validation program
• Organizes and presents (either written or verbally) their work
• 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
• Contributes to mentoring activities for the development of the Validation team
• Contributes Validation input and represents the Validation department on cross-functional teams
• Independently initiates, designs, and evaluates plans for site projects, responsible for planning and execution of all tasks needed to meet goals. Executes priorities and begins to consider long range project planning with consultation with supervisor, good project and personnel management skills are required
• No supervision for day-to-day activities required, meets regularly with supervisor to update on progress towards long-term goals
• Leads the preparation and execution of validation protocols, data analysis and final reporting.
• Provide validation input and direct support during regulatory inspections
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Implement department action plans based on the results from internal or external audits, CAPA and exception management processes
• Manage the work for day-to-day validation operations
• Contributes to policies and procedures required to ensure compliance
• Support HA/ISO inspections
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

 

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 33lbs/15kg 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 su