Validation Lead Engineer (Supervisor)

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?
The Position
This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for the design, implementation, and troubleshooting of manufacturing processes, instrumentation, and equipment start-ups from the laboratory through manufacturing scale. This individual provides coaching and direction for cell culture, fermentation, purification, engineering, design, validation, and scale-up. Prior supervisory/leadership experience is preferred, including in a matrixed environment.
This is an onsite based role Monday-Friday. Relocation Assistance is eligible for selected candidate.
Relationships
Reports to: Manager of Validation & Manufacturing Engineering
Number of subordinates with direct/indirect referral: Approximately 6-7 direct reports
Essential Functions

• Hire, train, develop and coach team members
• Align individual performance expectations with organizational goals
• Develop performance goals collaboratively with direct reports
• Ensure that performance goals are clearly communicated and current
• Provide constructive and timely feedback towards performance expectations and goals
• Coaches team members and leads process and equipment troubleshooting to support deviations, corrective actions and related issues
• Technically independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the development of the team
• Initiate and oversee projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules
• 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
• System owner for equipment qualification, laboratory equipment qualification, facility/utility qualification, control system qualification, computerized equipment qualification, revalidation program, as well as associated systems and procedures
• Contributes to long-term strategic development of validation program and organizes the strategy into actionable deliverables for validation team. Develops project strategy aligning with validation and project management programs
• Provide validation input and direct support during audits and inspections, including presenting directly to auditor/inspectors. Coaches team on presenting in audits and inspections
• Provides technical support to team, including analyzing and interpreting validation data and making independent tactical decisions based on data
• Other duties as assigned

Development of People
Supervisory
Ensure that reporting personnel have individual development plans (IDP), 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.
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.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications

• Education and Certifications:
  • Bachelor's degree in an engineering or technical discipline required
  • Master's degree in engineering or related discipline preferred
• Work Experience:
  • Bachelor's degree with a minimum of six (6) years' related experience required
  • Master's degree with at least four (4) year's related experience preferred
  • Previous supervisory experience (direct or indirect) or leadership development training preferred

• Knowledge, Skills, and Abilities:
  • Normally receives no instructions on routine work, general instructions on new assignments. Knowledge of Automation
  • GMPs, Compliance, and Regulatory requirements is essential
  • Excellent communication skills and ability to work in a high-paced team-oriented environment

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 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%.
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.