Senior Validation Engineer

at  Novo Nordisk

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
• 36 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

PHYSICAL REQUIREMENTS

Ability to lift up to 30 lbs. with assistance. Ability to work in confined spaces and near operating equipment. Ability to be clean room certified. Ability to accommodate extensive international travel. Ability to work in loud noise environments. Ability to work hours necessary to support project, 24/7 production and /or maintenance activities. Travel: 0- 5%.

QUALIFICATIONS

• Education and Certifications:
• Bachelor’s degree or equivalent experience in life sciences or engineering
• Work Experience:
• A minimum of eight (8) years validation experience in the pharmaceutical or biotechnology industry
• Knowledge, Skills, and Abilities:
• Experienced professional with a strong understanding of area of commissioning, qualification and validation of facilities, utilities and equipment. Highly proficient in a wide-range of technical abilities
• Demonstrated independence in solving problems of diverse scope and complexity
• Bachelor’s degree or equivalent experience in life sciences or engineering
• A minimum of eight (8) years validation experience in the pharmaceutical or biotechnology industry
• Accuracy in interpreting data and formulating conclusions
• Readily identifies next steps in process. Expert understanding of GMP and quality processes and current industry risk based management systems and approach
• 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
  We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
  At Novo Nordisk we recognize that it is no longer 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 know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
  Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
  If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications

• Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation
• Support of internal and external audits
• 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 operational validation support 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