Manufacturing Engineer II
Lupin Pharmaceuticals
Florida, United States
Engineering, Information Technology
Job Description
- Contribute to design transfer and continuous improvement activities by cross-functional team engagement and stakeholder management to support New Product Introduction and Sustaining Activities
- Collaborate with Quality to establish manufacturing process controls & quality controls on existing and new products
- Creates and maintains manufacturing documents including engineering drawings, BOMs & Travelers, manufacturing process instructions, and engineering change orders
- Coordinating engineering and production builds, including drafting manufacturing process instructions
- Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes.
- Authors and perform process development activities including but not limited to Process Development, Preventive Maintenance & Calibration Requirements, IQ / OQ / PQ.
- Demonstrates application of Design or Experiments, SPC, Process Capability, Gage R&R and MSA for the Manufacturing Process Controls.
- Authors and utilize xFMEAs to identify and address potential manufacturing defects, and minimize risk to patient safety.
- Ability to solve complex technical problems with equipment and/or manufacturing processes using 5-why, Fishbone, Is-Is Not frameworks.
- Able to understand and operate semi-automatic, and automatic assembly equipment to assemble drug device combination products.
- Participate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, with the help of internal subject matter experts.
- Update and maintain engineering documents and files in accordance with company policy.
- Responsible for identifying and addressing line issues including but not limited to manufacturing process and component non-conformances, Deviations, Equipment inefficiencies.
- Employ Design for Manufacturing/Assembly (DFx) during product development and manufacturing process development.
- Design, develop and procure tooling, fixtures, and equipment in Solidworks.
- Ensure adherence to the applicable Standard Operating Procedures of the Quality System.
- Minimum: BS or MS in Mechanical Engineering or equivalent and 3 Years of experience
- Highly Desirable: Experience in medical device industry and pharmaceutical development experience.
- Some experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualifications desirable.
- Ability to deploy Lean Manufacturing and Six-sigma principles for continuous improvement.
- Experience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards).
- Prior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers is preferred.
- Leadership and coaching skills.
- Demonstrated ability to communicate effectively and professionally with diverse stakeholders, including management, cross-functional teams, customers, and suppliers, across both technical and non-technical domains and multicultural environments.
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
About the company
Company website•Pharmaceutical Manufacturing
Lupin Pharmaceuticals, Inc. is the U.S. subsidiary of Lupin Limited, a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
In the U.S., Lupin has been expanding its footprint with headquarters in Naples, Florida, corporate offices in Bridgewater, New Jersey, and R&D and manufacturing facilities in Coral Springs, Florida, and Somerset, New Jersey. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals.