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.
To support the manufacture of Commercial Gliadel wafers, including execution of approved SOPs and batch records to produce a quality product according to GMP guidelines. Takes responsibility for manufacturing a quality product, performs equipment cleaning and maintenance per approved procedures, reviews and edits documentation, and supports protocol execution and equipment maintenance.
1. Product Manufacturing /GMP Compliance
- Manufactures product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
- Performs set-up, dismantling and maintenance of equipment and assures equipment is ready for production operations.
- Completes cleaning of equipment/glassware according to SOP’s.
- Weighs chemicals accurately.
- Participates in all processes of manufacturing.
- Prepares solutions for production area cleaning and performs routine cleaning of areas.
- Conducts manufacturing activities to protect themselves, others, and company assets.
- Complies with SOPs, Batch Records, and other GMP documentation.
- Reviews work of self and others to ensure accuracy and compliance with good documentation practices.
- Completes & reviews batch records ensuring the accuracy of the document prior to review by management.
- Reports any compliance issues to Manufacturing Manager.
2. Process Improvement/ Documentation Management
- Reviews and edits SOPs, batch records, and other documentation.
- Ensures that routine audits are completed accurately and in a timely manner
- Edits qualification protocols for new and/or existing equipment or systems
- Requests Production Batch Records from QA at least one week prior to scheduled production.
- Identifies process improvement opportunities and offers suggestions.
- Participates in trending of processes and/or processing parameters and provide initial evaluation of the data – notifying Manufacturing Manager of trends.
- Participates in execution of protocols & experiments to resolve issues and find solutions.
- Recommends scheduling or other efficiency improvements as indicated.
3. Equipment Maintenance /Troubleshooting
- Performs equipment maintenance such as periodic equipment cleaning, inspection, and filter changes, etc.
- Trouble shoots equipment as necessary during production operations.
- Maintains inventory of equipment and supplies and ensures the availability for production activities.
4. Training / Personal Development
- Completes annual GMP & safety training.
- Participates in on-going training.
- Assists in training new and existing employees
- Continues SOP training as it pertains to daily tasks & participates in on the job training.
- Develops new skills and knowledge which are beneficial to self and organization.
- Cross trains to support other departments
- Other duties as required to support the Gliadel organization
- 2-4 year college education in a scientific discipline
- 0-2 years minimum work experience in a GMP environment
- Experience with GMP commercial product manufacturing of pharmaceutical products
- Prior Cleanroom experience preferred
- Knowledge of US and EU GMP regulations
- Working knowledge of MS Word, Excel, Outlook and TEAMS a plus
- Ability to gown according to GMP guidelines required.
- Incumbent must be able to lift up to 50 lbs., stand for long periods of time, stoop or bend if necessary and operate manufacturing equipment.
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.
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