Manufacturing Tech II

Eisai US; Baltimore (MD); Vor Ort; USD 34.000 - 45.000; Vollzeit

Zusammenfassung

Eisai US is seeking a Manufacturing Technician II to support the production of commercial Gliadel wafers. The role focuses on GMP-compliant manufacturing, packaging, and labeling, with emphasis on quality and documentation.

You'll perform equipment setup and maintenance, help review batch records, and participate in EHS and training programs to ensure safe, efficient operations in a fast-paced pharmaceutical environment.

Qualifikationen

• 2-4 year college education in Chemistry or other scientific discipline preferred.
• A minimum of 1.5 years of work experience in a GMP environment preferred.
• Experience with GMP commercial product manufacturing.
• Packaging and labeling experience desired, but not required.
• Knowledge of US and EU GMP regulations.
• Working knowledge of MS Word, Excel and Outlook a plus.
• 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.

Aufgaben

• Manufactures, packages, and labels product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
• Produce polymer materials through controlled chemical synthesis methods.
• Performs set-up, dismantling and maintenance of equipment and ensures equipment is ready for production operations.
• Completes cleaning of equipment/glassware according to SOP’s.
• Weighs chemicals accurately.
• Participates in all processes of manufacturing, packaging, and labeling.
• Prepares solutions for production area cleaning and performs routine cleaning of areas.
• Conducts manufacturing activities to protect themselves, others, and company assets.

Kenntnisse

GMP compliance

Manufacturing

Documentation

MS Word

Excel

Outlook

Ausbildung

2-4 year college education in Chemistry or other scientific discipline

GMP environment experience

Tools

MS Word

Excel

Outlook

Jobbeschreibung

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 Manufacturing Technician II supports 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, packaging, and labeling of a quality product in accordance with FDA, EU and JP Good Manufacturing Practices (GMP). Additional duties include performing equipment cleaning and maintenance per approved procedures, reviewing and revising documentation, and supporting protocol execution and EHS programs as assigned.

Essential Functions:

1. Product Manufacturing /GMP Compliance

• Manufactures, packages, and labels product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
• Produce polymer materials through controlled chemical synthesis methods.
• Performs set-up, dismantling and maintenance of equipment and ensures equipment is ready for production operations.
• Completes cleaning of equipment/glassware according to SOP’s.
• Weighs chemicals accurately.
• Participates in all processes of manufacturing, packaging, and labeling.
• 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 leadership
  

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
• 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 leadership 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.
• Troubleshoots equipment as necessary during production operations.
• Maintains inventory of equipment and supplies and ensures the availability for production activities.
  

4. EHS Programs

• Supports the Hazardous Waste Program as a Hazardous Waste Coordinator.
• Performs monthly safety audits.
  

5. 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
  

Requirements:

• 2-4 year college education in Chemistry or other scientific discipline preferred
• A minimum of 1.5 years of work experience in a GMP environment preferred.
• Experience with GMP commercial product manufacturing
• Packaging and labeling experience desired, but not required
• Knowledge of US and EU GMP regulations
• Working knowledge of MS Word, Excel and Outlook a plus
• 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 Salary Transparency Language:

The hourly rate for the Manufacturing Tech II is from :$25-$33. Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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