Manufacturing Tech II

Eisai US•Baltimore, MD

4d•$24 - $32•Onsite

About The Position

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.

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.
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

Nice To Haves

Experience with GMP commercial product manufacturing
Packaging and labeling experience desired, but not required

Responsibilities

Product Manufacturing /GMP Compliance Manufactures, packages, and labels 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 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
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.
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.
EHS Programs Supports the Hazardous Waste Program as a Hazardous Waste Coordinator.
Performs monthly safety audits.
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