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 Fifteen 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.

Essential Duties and Responsibilities

• Interact with operations, manufacturing, and other internal subject matter experts to define, design, test, implement, and support high-quality, efficient, and cost-effective manufacturing processes
• Coordinate with Quality and establish process controls on existing and new products.
• Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes.
• Able to understand and operate semi complex to complex assembly equipment to assemble drug device combination products
• Participate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, with help of internal subject matter experts
• Update and maintain engineering documents and files in accordance with Company policy
• Participate in customer meetings to discuss designs, schedules and other relevant matters
• Help in the documentation work and the development of a high-quality Design History Files (DHF).
• Responsible for identifying and correcting manufacturing process nonconformance’s identified during prototype builds
• Support technical development as it relates to manufacturing prototype devices for testing
• Develops and procures tooling, fixtures, and equipment used in manufacturing that optimize productivity, maintainability, and cost.
• Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
• Interfaces with Quality and R&D to integrate new products or processes
• Coordinates with the manufacturing site on product transfers by leading the design transfer process
• Supports the manufacturing site on any design or process related changes.
• Creates and maintains manufacturing documents including engineering drawings, BOMs, process work instructions, and engineering change orders
• Coordinating engineering and production builds, including drafting manufacturing work instructions
• Leads equipment qualification and process validation tasks
• Conduct Process FMEAs and Process Validations

Education and Experience

• Minimum: relevant degree in Engineering and at least 5-6 years of experience in a similar area
• Highly Desirable: Experience in medical device industry and pharmaceutical development experience.
• Successfully demonstrated expertise in medical devices area.
• Some experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualification desirable. Proficient in utilization and qualification of special tools/equipment for force measurement and metrology.
• Additional background in Material Sciences a plus.
• Experience with documentation of medical devices and drug product combination products, including Design Control process and development of Design History File(s).
• Experience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards).
• Experience with software tools required in medical device industry (e.g., Solid Works, CAD etc.) in addition to general software and computer tools.
• Prior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers preferred.
• Ability to work in and/or lead teams.
• Leadership and advanced coaching skills. Ability to work in a matrix organization.
• Very good communication skills. Good presentation skills and scientific/technical writing skills.

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 law.

Physical Requirements

The 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 environment.

Search Firm Representatives Please Read Carefully 

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 emails