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.
Responsibilities
Role Summary
The Engineering Maintenance Lead will report to the Engineering, EHS & Facilities Department. The Engineering Maintenance Lead at Lupin Coral Springs is expected to lead maintenance and continuous improvement activities for the R&D, Manufacturing and major laboratory equipment, utilities and facilities to establish world-class reliability. This role will work on the development and implementation of procedures, systems, and overall program to support R&D and Commercial operations at Lupin Coral Springs Site. Assist with investigations due to anomalous or OOC results as required.
Essential Duties And Responsibilities
- Manages, plans, coordinates, and prepares timely execution of daily activities and PM Schedule related to facility operation, corrective, preventative and predictive maintenance, and repair for all pieces of equipment and instrumentation used during the R&D, Manufacturing and or laboratory operation, this may include the use of third-party vendors such as manufacturer, manufacturer’s authorized dealers, or qualified contractors.
- Ensure that PM records are adequately produced and maintained in accordance with regulatory requirements.
- Review and continuous improvement of Standard Operating Procedures, forms, templates and any necessary tool to meet customer’s and regulatory agencies’ expectations.
- Capture and monitor work orders as they relate to Engineering and Facilities matters.
- Collaborates with colleagues and external partners to achieve primary department goals
- Exercise strong problem-solving ability and troubleshooting of manufacturing & laboratory instruments
- In support of other groups/departments, executes investigations and CAPA-related activities
- Adhere to cGMP and safety procedures
- Notify management of any observations or deviations
- Work with Metrology team to ensures all critical instruments are in calibration status.
- Maintain facilities all the time to acceptable level of FDA, OSHA and environmental agency compliance. Assist in maintaining Engineering Documentation up to date to the requirements of FDA, EU, OSHA, etc. Assist in the preparing and maintaining site for any audits. Implements audit report recommendations as applicable.
- Provide support and assistance with facility related upkeep and general maintenance. Respond to Service Requests for troubleshooting and repair of facilities.
- Assist in the management and procurement of spare parts and equipment in line with established processes, ensuring availability for planned maintenance and unplanned repair.
- Responsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment.
- Other duties as assigned.
Qualifications
Education & Experience
- Bachelor's Degree in a Scientific Field or Associate Degree with relevant experience in this field.
- Minimum of 5 years of pharmaceutical industry experience leading in maintenance department.
- Experience with maintenance of laboratory equipment such as GC, HPLC, UPLC, dissolution apparatus, FTIR as well as manufacturing equipment such as Blenders, Pouch Sealers, Tray Sealers, etc.
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 to 25 pounds occasionally. This is an on-site position.
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.
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