Manufacturing Area Specialist I - III

Novo Nordisk • West Lebanon, NH • 4w ago

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

14 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 manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems.

Relationships

Reports to: Manager API Manufacturing

Number of subordinates with direct/indirect referral: n/a

Essential Functions

Liaison between Production Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis

Review/approval of completed process documentation

Ability to train others on the manufacturing process and QMS systems

Revise and create documentation (SOP, batch records, FT's) associated with the manufacture of product, requiring minimal direction

Ability to investigate and write up Deviation events utilizing Root Cause Analysis

Incorporate pre-planned process improvements and cost reduction projects into manufacturing

Ability to take on and manage multi-disciplined projects, with minimal supervision

Understanding/application of quality systems

Support of Health Authority inspections

Possesses technical and systems knowledge and can research information outside of knowledge base

May need to support hands-on manufacturing within the given area for production coverage

Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment

Support activities in other departments as instructed by manager

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

Qualifications

Education and Certifications

High School diploma or equivalent with a minimum of six (6) years relevant manufacturing experience or a Bachelor's degree or equivalent in a science or engineering discipline with three (3) or more years of experience

Work Experience

Six (6) years relevant manufacturing experience with High School Diploma or equivalent

Bachelors degree or equivalent with three (3) years of experience

Pharmaceutical or biotechnology strongly preferred

Knowledge, Skills, and Abilities

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

Excellent communication skills-articulates ideas and concepts clearly to all audiences

Physical Requirements

0-10% overnight travel required. The ability to finger, climb, and walk. The ability to speak, listen, and understand verbal and written communication. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations.

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.

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