Job description
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Packaging Operator II is responsible for conducting daily packaging and labeling activities for Gliadel® Wafer and ensuring all work activities are in accordance with FDA, EU and JP Good Manufacturing Practices (GMP). This position will participate in non-manufacturing production activities (to include labeling and packaging tasks), and will be responsible for ensuring exceptional quality standards in accordance with Eisai’s
human health care (
hhc) mission. Activities include preparation of inner foil pouches for irradiation, labeling of outer foil pouches, packaging product for irradiation, packaging of irradiated product into final format, and preparation of product for shipment for processing (irradiation) and/or shipment to partners, and training new employees to the Packaging team. As an experienced operator, this position operates with minimal supervision.
Assist Shipping and Receiving and Logistics as needed to support Gliadel Operations.
Essential Functions
Packaging and Labeling
- Set up and operate the packaging operation with minimum down time and interventions.
- Perform all cleaning, line clearance, staging, set-up and batch reconciliation activities to support the packaging operations.
- Conduct activities following proper procedures and in accordance with SOPs and batch record instructions.
Documentation
- Document all production activities on the master batch record to comply with GMP and GDP requirements.
- Participate in the creation, revision, and review of Standard Operating Procedures (SOP) and Master Batch Records as necessary.
Assist with manufacturing deviation investigations, CAPAs and other related quality concerns. Takes lead in completing preventative maintenance work orders; as well as the Packaging Quarterly Audit.
Will demonstrate mastery of duties by training and mentoring new Packaging department staff.
Cross train to provide support to Logistics and Shipping & Receiving operations as needed.
Requirements
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High School Diploma required; 1-2 years college preferred .
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Minimum 2 years prior Pharmaceutical GMP experience is required.
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Ability to work independently.
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Demonstrated ability to accurately train new Packaging operators
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Ability to operate labeling equipment, computerized labeling systems and plant utilities services such as compressed process air.
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Requires good communication, teamwork and collaboration.
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Ability to clearly and accurately document work.
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Professional attitude and detail orientation. Ability to troubleshoot minor to immediate issues.
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Requires the ability to stand for prolonged periods (> 4 hours).
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Requires the ability to sit, inspect and count packaged product for prolonged periods
(> 4 hours). -
Must have 20-20 vision (vision correction lenses acceptable).
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Requires the lifting of heavy objects (up to 50 lbs).
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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