Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

RESPONSIBILITY:

• Design and development of drug combination products using mix of engineering principles, analytical, and experimental method
• sIdentify the best tools and approaches to effectively solve engineering problems
• .To develop, optimize and/or analyze designs by applying the appropriate
• .Must have good knowledge of manufacturing principles as well as geometric dimensioning and tolerance tools
• .Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.3
• 0Support documentation activities for MDR device registration in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient and compliant manne
• rCreates and updates technical documentation to achieve and maintain MDR certificatio
• nAssists regulatory affairs in the preparation and submission of new products for the EU marke
• tDetermines the regulatory impact of proposed product changes on EU registration
• sProvide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific accuracy, and clarity of presentatio
• nSupport execution of technical and/or cross-functional project work
• .Implement test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
• .Ensure compliance with Lupin quality policies, standard operating procedures and practice

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QUALIFICATION

• S:BS degree in Engineering (Mechanical Engineering, Biomedical Engineering or a closely related engineering degree required
• ).Minimum of 4 years of engineering experience or equivalent and compiling documentation for US FDA submission and EU MDR is requir
• edDemonstrated accountability for successful completion of designated task
• s.Understanding of disciplined product development processes and quality requirement

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Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable l

aw.
Physical Requirem

entsThe physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environm

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Search Firm Representatives Please Read Caref

ully Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or e