Engineering Area Specialist

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.

 

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

 

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 has primary responsibility to support technical operations. Assists in coordination and execution of process and equipment improvement programs, investigates deviations, and implements corrective/preventative actions via change requests, document change controls, and developing training.

 

Relationships

Reports to: According to the organizational chart.

 

Direct reports: none

 

Essential Functions

• Liaison between Engineering and manufacturing for the coordination of process/equipment improvements
• Ability to investigate and write up Deviations events utilizing Root Cause Analysis
• Utilize the quality system to implement changes associated with technical operations, engineering, and/or validation (generate, execute, and evaluate change requests)
• Revise and create documentation (SOP, batch records, reports) associated with technical operations, production, engineering, and validation
• Incorporate technical pre-planned process improvements and cost reduction projects into manufacturing
• Develop training for engineering/validation or production with direction from engineers
• Support Health Authority inspections and internal audits
• Ability to take on and manage multi-disciplined projects, with minimal supervision
• Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance
• 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
• Other duties as assigned

 

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. Visual acuity to perform close activities such as: reading, writing, and analyzing. Lifting up to 33 lbs/15 kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. 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%.

 

Qualifications

• Education and Certifications:
  • Bachelors degree (or equivalent) required, in a scientific or engineering discipline preferred
• Work Experience:
  • A minimum of one (1) year of engineering, validation, or technical operations related experience
  • Pharmaceutical or biotechnology strongly preferred

• Knowledge, Skills, and Abilities:
  • Ability to follow routine work instructions for new and ongoing projects and assignments
  • Excellent communication skills and ability to work in a high-paced team-oriented environment
  • Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines
  • Ability to understand and execute established written instructions is essential
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail
  • Demonstrate a practical understanding of lean manufacturing principles
  • Analytical abilities and problem-solving skills
  • A strong work ethic (self-motivated), honesty, excellent communication skills, and the ability to work in teams – displays initiative and commitment

 

We commit to an inclusive rec