Associate Engineer II - Lupin Pharmaceuticals Inc.

Overview

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.

Responsibilities

Role and Responsibilities

This position will support operations from an equipment/process expert role within both manufacturing and packaging departments in Somerset, NJ. Reporting to the Operations Director, associate engineers lead continuous improvement opportunities at the site, investigate process and equipment upsets through root cause problem solving methodologies, develop project plans to correct and implement solutions, and drive efficiencies initiatives within operations.  The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.

• Associate engineer II demonstrates working knowledge of equipment and processes in the manufacturing and/or packaging of pharmaceuticals and able to take initiatives to advance departmental goals.
• Create, revise, and maintain documents such as change controls, standard operating procedures, and qualification protocols.
• Lead deviation and customer complaints investigations as assigned 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 manufacturing and 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 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 required occasionally and flexing of hours needed to interface with operations shifts during projects, investigations, and training.
• Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.

Qualifications

Qualifications and Education Requirements

• Bachelor’s Degree in an engineering or scientific field. Chemical or Mechanical Engineering preferred.
• OR 15 years equivalent job experience in pharmaceutical operations
• Minimum 2 – 6 years of pharmaceutical operations experience.
• Strong communication and 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