Process Engineer Level I-II (Downstream) jobs in United States
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Novo Nordisk · 22 hours ago

Process Engineer Level I-II (Downstream)

Novo Nordisk is a leading healthcare company focused on solutions for chronic diseases. The Process Engineer will support bioproduction downstream purification processes, ensuring efficient production and compliance with cGMP requirements while collaborating with cross-functional teams.

BiotechnologyHealth CareMedicalPharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Assist with SOPs, JIs, DVs and other production documentation to the shopfloor
Participate in the development and implementation of procedural or automation improvement changes
Participate in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiatives and support colleagues
Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
Maintain effective communication and ensure alignment in coordination with appropriate teams
Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations
Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations
Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed
Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
Participate in on-call rotations, including weekends and non-business hours, to provide support
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

Qualification

GMP knowledgeBiopharmaceutical equipmentProcess engineeringAutomation knowledgeRisk-based verificationCommunicationTeam-orientedTechnical writing

Required

Bachelor's degree in engineering or related discipline required
Bachelor's degree with three (3) years related experience required
Ability to follow routine work instructions for new and ongoing projects and assignments
Excellent written and verbal communication skills a must
Excellent communication skills and ability to work in a high-paced team-oriented environment
Ability to provide evening, nighttime, and weekend on call support as needed
Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes
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
Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
Visual acuity to perform close activities such as: reading, writing, and analyzing; and visual inspection

Preferred

Medium to large scale pharmaceutical or biotechnology process experience preferred
Knowledge of Automation and GMPs requirements preferred
Broad understanding of science and risk-based verification (I.E. ASTM E2500)
Knowledge of good engineering practices
Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred

Benefits

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

Company

Novo Nordisk

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Novo Nordisk is a healthcare company that produces and distributes insulin and other diabetes drugs to treat chronic diseases.

H1B Sponsorship

Novo Nordisk has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (21)
2023 (13)
2022 (10)
2021 (9)
2020 (12)

Funding

Current Stage
Public Company
Total Funding
$22M
2018-12-05Post Ipo Equity· $22M
1981-07-09IPO

Leadership Team

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Lars Fruergaard Jørgensen
President and CEO
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Lars Sorensen
President & CEO
Company data provided by crunchbase