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.

Role and Responsibilities

This position will support facility and utility operations from an equipment/process expert role within the engineering departments in Somerset, NJ. Reporting to the Engineering Director, Engineers lead CapEx projects at the site, develop project plans to correct and implement technical solutions to existing facilities, equipment and systems, and drive improvements through root cause problem solving methodologies.  Sr. Engineers also set technical direction for others and develop and implement standards to advance objectives.  The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.

• Associate engineer II demonstrates working knowledge of equipment and processes in facilities, HVAC, or utility systems or have skills within manufacturing and/or packaging of pharmaceuticals from a project delivery role. and able to take initiatives to advance departmental goals.
• Create, revise, and maintain documents such as change controls, standard operating procedures, and qualification protocols.
• Responsible for SOP Creation, and modifications
• Reviewing and supervising HVAC and Utility preventative maintenance.  
• Lead deviation investigations in areas of responsibilities through use of root cause problem solving tools and technical knowledge / understanding to identify and propose corrective and preventive actions. Able to technically write and prepare written investigations of findings and conclusions.
• Lead continuous improvement initiatives within facilities, manufacturing or packaging in support of operations. Emphasis is on error reduction, lean waste elimination, and reduced process variation that improves product safety, quality, and efficiency.
• Lead projects within facilities, manufacturing and packaging for capital investments. Will create, revise, and maintain project documentations include scope, user requirements, voice of customer, design schedules, implementation schedules, resource needs, cost tracking and control, and team meetings and coordination visuals and other materials.
• Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.
• Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.
• Under the supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work and projects led to enable leader’s review and approval and occasional direction in performing one’s work.
• Working hours typically 8 to 5 Monday through Friday or other as approved by supervisor. Some off-hour shift support may be occasionally be needed and flexing of hours to interface with operations shifts.
• Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.

Qualifications and Education Requirements

• Bachelor’s Degree in an engineering or scientific field. Chemical or Mechanical Engineering preferred.
• Minimum 2 – 6 years of pharmaceutical operations experience.
• Project experience in manufacturing/packaging OR technical working knowledge in facilities or utility systems.
• Strong communication and technical writing skills.

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 35 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.