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Lilly Manufacturing Coordinator in Branchburg, New Jersey

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Senior Specialist – MFG – LBB

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description:

This position is responsible for providing support to their respective process team per Manufacturing Standard for Operational Excellence (MSOE) 602, specifically focusing on safety, quality and manufacturing performance. Providing departmental support to meet processing timelines while ensuring strict adherence to safety and quality requirements. Provide a point of contact for interdepartmental communication, scheduling, execution, and allocation of resources to support projects for all departments supporting manufacturing. Track and assist with the resolution of process irregularities. Schedule activities, communicate information, and assist supervisors with any activities to ensure a seamless transition between shifts. Strive for excellence with an emphasis on integrity and respect for people.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

  • Responsible for providing support to their respective process team, per Manufacturing Standard for Operational Excellence (MSOE) 602.

  • Coordinate work with other departments, including but not limited to the following: Manufacturing Technology, Validation, Engineering, Facilities, Metrology, Utilities, Manufacturing US & DS, QA and QC.

  • Schedule validation studies, equipment validation, engineering projects, change controls, calibrations, equipment maintenance, and other project-oriented work.

  • Communicate project status to manager.

  • Coordinate and track execution of Product Changeover.

  • Perform duties of Supervisor in Supervisor’s absence.

  • Author, review, and approve Batch Records, Protocols, SOP’s, Forms, ECPs, and job plans. Could lead or facilitate the execution of PmatchesP of SOP.

  • Perform NCE investigations, RCA, and create and execute CAPAs.

  • Department representative for internal area inspections (QA and HSE) and observation resolution.

  • Department representative for interdepartmental meeting and responsible for delineation of information to department.

  • Track NCEs and process irregularities.

  • Maintain production schedule and process team meeting minutes.

  • Monitor and address BSAFEs. Communicate safety issues to management in a timely manner.

  • Provide input and assist with process improvements.

  • Adhere to all safety, environmental, quality, and EEO/AA standards and policies of the Corporation.

  • Comply with cGMP requirements.

Basic Requirements:

  • BA/BS in biology, chemistry, or related discipline, or equivalent work experience.

  • Minimum of 2-5 years of relevant experience, or a minimum of 2 years high performance as Operator I.

  • Demonstrated level of high technical understanding of operations within functional area.

Additional Information:

  • Must be able to follow detailed instructions and record information clearly and accurately.

  • Must have good manual dexterity and demonstrated mechanical aptitude.

  • Must possess excellent communication, interpersonal, and written skills.

  • Demonstrated knowledge and experience in aseptic processing techniques.

  • Must be able to apply technical and operational experience to aid in problem solving activities.

  • Must meet the physical requirements of the job; must have the ability to:

  • Must have the ability to lift a minimum of 25 lbs.

  • Must have the ability to bend, reach, stretch, climb ladders, and work in tight spaces in order to complete job tasks.

  • Must have the ability to stand for long periods

  • Wear appropriate clean room attire.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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