API Manufacturing Associate I
Company: Novo Nordisk
Location: Clayton
Posted on: January 27, 2023
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Job Description:
About the Department
At Novo Nordisk, we are helping to improve the quality of life for
millions of people worldwide. For nearly 100 years, we have led the
way in diabetes care. Being part of Novo Nordisk allows our
employees to embark on life-changing careers, and the opportunity
to help improve the quality of life for millions of people around
the world.
In NC, we operate three pharmaceutical manufacturing facilities
that are responsible for fulfilling different steps in our
injectable and oral treatment supply chains. Our newer Active
Pharmaceutical Ingredients (API) facility in Clayton, NC sits on
825,000 square-feet of state-of-the-art equipment, and houses the
Fermentation, Recovery and Purification in the production of
ingredients for Novo Nordisk's innovative oral products. At API,
you'll join a global network of manufacturing professionals who are
passionate about what they do.
What we offer you:
* Leading pay and annual performance bonus for all positions
* All employees enjoy generous paid time off including 14 paid
holidays
* Health Insurance, Dental Insurance, Vision Insurance - effective
day one
* Guaranteed 8% 401K contribution plus individual company match
option
* Family Focused Benefits including 12 weeks paid parental & 6
weeks paid family medical leave
* Free access to Novo Nordisk-marketed pharmaceutical products
* Tuition Assistance - reimbursement up to $10,000 annually
* Life & Disability Insurance
* Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and
mentorship to help grow and build your career. Are you ready to
realize your potential? Join Team Novo Nordisk and help us make
what matters.
Position Purpose
Operate API manufacturing equipment to achieve production
goals.
Accountabilities
* Work in a safe & environmentally responsible manner
* Follow instructions listed in GMP documentation & product
quality
* Review SOP's & other documents, as required
* Real time review of electronic batch records ensuring compliance
to Standard Operating Procedures (SOPs) & current Good
Manufacturing Practices (cGMP) standards
* Manage individual training plan
* Participate in qualification & validation activities as
required
* Setup, operate, monitor, & control highly automated processes &
systems
* Load & unload product from trucks, tankers & ISO containers, as
required
* Execute production schedule to achieve production goals
* Utilize investigation skills during troubleshooting & assist
during equipment maintenance, including restoration of lost
function, predictive & preventative maintenance
* Maintain clean room areas & perform environmental monitoring, as
required
* Other accountabilities, as assigned
Required Qualifications
* High school graduate or equivalent
* Computer literacy including, but not limited to, ability to
operate computer driven manufacturing/production equipment &
efficient use of Microsoft Office suite programs
* Ability to read & understand complicated product documentation &
standard operating procedures with attention to detail
* Ability to perform basic material handling tasks, safely &
effectively use material handling equipment
* Ensure compliance with corporate/local SOPs, regulations & ISO
standards
* General knowledge in cGMP manufacturing & production processes
associated with pharmaceutical companies
Desired Qualifications
* AA/AS/AAS degree or higher in Tech, Science, or Engineering
* BioWork or equivalent industrial, military or vocational training
combined with experience
* Minimum two (2) years of manufacturing experience in FDA
regulated environment
* Experience demonstrating a systematic approach to problem solving
& troubleshooting based on data & facts. Actively participated in &
driven event response activities. Documented problems & worked on
ensuring rapid resolution & preventing recurrence
* Experience following SOPs to perform tasks & raising issues if
errors are found
* Experience following established safety guidelines when
performing tasks
* Basic knowledge of biology/chemistry
* Mechanical aptitude, ability to follow use tools to perform
tasks, basic troubleshooting of mechanical components & systems
* Experience working with work permits/Lock Out Tag Out systems
Physical & Other Requirements
* Ability to move equipment and/or supplies weighing up to 50 lbs.
within facility
* Ability to routinely operate & inspect manufacturing equipment
using hands
* Ability to constantly position oneself to transfer materials
within manufacturing environment
* Ability to frequently move about the building to access other
personnel & operational areas
* Ability to move throughout facility to interact with other
employees in the normal office & manufacturing environment
* Corrected vision to 20/30 and/or ability to pass vision screening
assessment necessary to procure motorized vehicle license
* Ability to ascend/descend a ladder to service equipment
* Ability to work atop elevated positions at heights
* Ability to secure a motorized vehicle license & operate motorized
equipment
* Ability to work around odorous &/or hazardous materials
* Ability to perform critical job functions in extremely cold work
environments
* Ability to work around mechanical equipment
* Ability to work hours as needed to support production including
on call, some evenings &/or weekends
* Ability to position oneself within confined spaces for
inspection, repair & maintenance of equipment
* Ability to work in loud noise environments with hearing
protection
* Ability to travel internationally, as requested
* Ability to attain clean room gowning certification
* Ability to stand on feet up to 12 hours or longer, day or
night
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.
Novo Nordisk requires all new hires to be fully vaccinated against
COVID-19 prior to the first date of employment. As required by
applicable law, Novo Nordisk will consider requests for reasonable
accommodation.
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.
Keywords: Novo Nordisk, Raleigh , API Manufacturing Associate I, Other , Clayton, North Carolina
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