Principal Engineer, Validation
Company: Novo Nordisk
Location: Bloomington
Posted on: July 8, 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
positionsAll employees enjoy generous paid time off including 14
paid holidays Health Insurance, Dental Insurance, Vision Insurance
– effective day oneGuaranteed 8% 401K contribution plus individual
company match optionFamily Focused Benefits including 14 weeks paid
parental & 6 weeks paid family medical leaveFree access to Novo
Nordisk-marketed pharmaceutical productsTuition Assistance Life &
Disability InsuranceEmployee 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
Primary purpose is to provide the validation of IT Systems for
system implementations, changes, & decommissioning. This includes
the validation strategy, documentation, protocol generation &
execution, & reporting in accordance to regulatory requirements &
company standards. Relationships Reports to Manager, IT, Validation
& Compliance Essential Functions Lead on requests and observation
responses by inspectors and auditorsParticipates in defining and
executing on the IT Validation and Compliance Team initiatives and
goalsCollaboration with the customer & SMEs on user, functional and
design requirements and their traceability through testing
verificationParticipate in FAT, SAT, commissioning and IQ/OQ
efforts for computerized equipment, analytical instruments,
automation/IT systems & business processesAuthor validation
documentation: validation plans, system assessments (system impact,
security, quality with focus on data integrity), system
specifications, SOPs, user guides, summary reports & other required
supporting documents to establish the validated stateGeneration &
execution of test protocols & system baselines for validated
systems per approved timeframes.Maintain the validated state of
computer systems through change management, periodic review,
requalification and data integrity assessments.Author
decommissioning documentation and ensure data integrity retention
requirements are met within the decommissioning plan appropriately
(decommissioning plans, assessments, abolishment/updates of
documentation, testing protocols & summary reports).Validation
Deviations & Investigations: Participate in investigations of
deviations per approved timeframes.Support validation deviations
root cause analysis. Strong understanding of process automation
code, network architecture, databases, automated instrumentation,
and/or application programming; able to develop risk-based
qualification strategies for systems in the area(s) of competence.
Other accountabilities, as assigned. Physical Requirements Must
comply with EHS responsibilities for the position.Repetition
including substantial movement of wrists, hands, and or fingers.The
ability to speak, listen, and understand verbal and written
communication.The ability to sit or stand at a desk for extended
periods of time. Qualifications Bachelor's Degree in Engineering,
Computer Science, or applicable technical degree required OR 10
years of experience in computer system validation or quality
related discipline in lieu of degree.Mastery in validation of
computer systems, operation, maintenance & decommissioning of
systems preferred.Mastery in GxP documentation practice preferred.
Mastery of GAMP compliance, FDA CFR 21 Part 11/EU Annex 11
preferred.Proficient in basic computer skills including experience
in the use of Microsoft Office required.Ability to write protocols
& technical documents with limited supervision required.Excellent
oral & written communication skills required.Strong knowledge of
regulatory audits & inspections preferred. 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: Novo Nordisk, Carmel , Principal Engineer, Validation, Engineering , Bloomington, Indiana
