1st Shift Specialist I, Formulation / Filling Mon-Fri 8AM-4:30PM
Location: Bloomington
Posted on: June 23, 2025
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Job Description:
About the Department At Novo Nordisk, we want to make a
difference. For more than 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. Our Bloomington, Indiana site is a state-of-the-art facility
where we have an integrated model from process and formulation to
clinical and commercial biomanufacturing and drug product
fill/finish and packaging. The Bloomington campus is a recognized
facility where talented teams work with innovators to help develop,
manufacture and supply products to patients around the world. 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 14 weeks
paid parental & 6 weeks paid family medical leave Free access to
Novo Nordisk-marketed pharmaceutical products Tuition Assistance
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.
The Position In general, this position provides direct technical
support to operations area as it relates to documentation,
equipment procurement, testing, operational excellence, and
training. This role works collaboratively with multiple company
functions to ensure production systems operate in a safe, and
quality-oriented manner. Relationships Reports to: Manager,
Form/Fill Essential Functions Provide direct technical support for
production processes and implementation of improvements Ownership
of Corrective Actions, Change Management, GMP document revision,
review and approval Participate and conduct continuous improvement
process changes Minimal interaction with Client and Regulatory
Auditors Has developed proficiency in a range of processes or
procedures through job-related training and considerable on-the-job
experience Continuous improvement participation Able to identify
areas of opportunities within the production processes and
formulate solutions Completes a variety of atypical assignments, as
needed Works within defined processes and procedures or
methodologies and may help determine the appropriate approach for
new assignments Completes work with a limited degree of supervision
Write and revise SOP’s and WI’s Likely to act as an informal
resource for colleagues with less experience Actively participates,
suggests solutions to problems, and drives to timelines Ensure
documentation is accurate and effectively assessing and mitigating
risk associated with manufacturing activities Create and assist in
implementation of Corrective and Preventative Actions (CAPAs)
Primary – Has developed advanced technical knowledge in a range of
processes or procedures through job-related training and
considerable on-the-job experience Completes a variety of atypical
assignments, as needed Completes work with limited supervision
Subject matter expert for processes and procedures within primary
manufacturing Proposes process improvements related to equipment
and processes Collaborates with Production Supervisors, Room Leads,
and QA floor support to solve issues real time Provides technical
knowledge of machine setup, troubleshooting, and maintaining
overall efficiency Develops training strategies for Primary
Operations Proficient in coaching and training floor operations in
all aspects of primary manufacturing Review and approve documents
in Electronic Data Management System (EDMS) Revise and route
documents through EDMS Executes other duties as assigned Secondary
– Equivalent technical expertise of process and equipment with that
of Senior Manufacturing Associate. Review and approve documents in
EDMS Revise department documents, and route through EDMS Provides
technical and floor support when required, and able to assist in
basic troubleshooting of process and equipment Proposed process
improvements and equipment improvements to MS&T, Engineering,
and QA as applicable Collaborates with Supervisors, Room Leads, QA
to solve issues real-time Executes other duties as assigned Minimal
interaction with Client and Regulatory Auditors Has developed
proficiency in a range of processes or procedures through
job-related training and considerable on-the-job experience Drug
Substance – Equivalent technical expertise of process and equipment
with that of Senior Manufacturing Associate. Review and approve
documents in EDMS Revise department documents, and route through
EDMS Review and revise process overviews, and process descriptions
Review and revise consumable designs and vendor drawings Provides
technical and floor support when required, and able to assist in
basic troubleshooting of process and equipment Proposed process
improvements and equipment improvements to MS&T, Engineering,
and QA as applicable Supports deviation investigators in CAPA
implementation and creation Supports department initiatives
involving continuous improvement Assists operators in with IT
related issues, and offers suggestions for new/improved equipment
Assists QA Batch Record Review with Client Observations, including
priority observations from QA Client Support Team Collaborates with
Supervisors, Room Leads, QA to solve issues real-time Provides
on-call support for alarm management and troubleshooting, as
necessary Creates and administers training content to elevate
technical knowledge on team Works scheduled shift and other
off-shift coverage as required Executes other duties as assigned
Ability to read and write English Perform basic math skills (, -,
x, /, %, understand decimals) Required to read, understand, and
follow GMP documents Has basic knowledge of the principles and
concepts of a discipline (e.g., Biology, Chemistry) Works
independently on limited scope issues Physical Requirements
Frequent sitting, standing, walking, reading of written documents
and use of computer monitor screen, reaching with hands and arms,
talking, writing, listening. Occasional stooping, kneeling,
crouching, bending, carrying, grasping. Frequent lifting and/or
moving up to 10 pounds and occasional lifting and/or moving up to
50 pounds. Must comply with EHS responsibilities for the position.
Working conditions will be Heating Ventilation and Air Conditioned
controlled. Ability to operate within a clean room environment as
needed. Qualifications Education/Experience: High School/GED
required 1-year pharmaceutical and/or manufacturing experience
required. 3 years preferred. 1-year GMP experience required. 3
years preferred. Technical Requirements: Proficient in Excel, Word,
and other office systems Utilization and familiarity of complex
software systems such as TrackWise®, ComplianceWire® and JD
Edwards®. Ability to understand and independently apply CGMPs as it
relates to clinical and commercial operations Demonstrates
understanding of the work tasks assigned Executes complex with high
quality Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines
Intermediate understanding of pharmaceutical laboratory and/or
production operations Capable of learning unfamiliar principles or
techniques with training Prior experience leading deviation
investigations using root cause analysis tools Champion change
control and corrective / preventative actions Ability to interpret
data and analyze trends and provide insight into potential issues
and suggest solutions Authors and/or approves Standard Operating
Procedures (SOPs), Batch Production Records (BPRs) and reports
Ability to lead technical calls and discussions regarding
investigations, audits, or other issues Seeks best practices for
daily work activities Ability to support Risk Assessments,
especially Hazard Analysis, Fault Tree Analysis, FMEA, etc. 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.
Keywords: , Indianapolis , 1st Shift Specialist I, Formulation / Filling Mon-Fri 8AM-4:30PM, Science, Research & Development , Bloomington, Indiana