Manufacturing Tech III
Logistics & Supply Chain Mgmt
January 22, 2019
Manufactures product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
Performs and oversees set-up, dismantling and maintenance of equipment and assures equipment is ready for production operations.
Inspects and assures equipment is in good repair and ready for production operations.
Performs routine sanitization of areas.
Completes cleaning, autoclaving & depyrogenating of equipment.
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.
Performs Spray Dry process and CIP as required.
Performs integrity tests on filters.
2. GMP Compliance / Documentation Management
Complies with SOPs, Batch Records, and other GMP documentation.
Reviews work of self and others to ensure accuracy and compliance with good documentation practices.
Assists in training new and existing employees
Reviews and edits SOPs, batch records, and other documentation.
Completes & reviews batch records ensuring the accuracy of the document prior to review by management
Participates in trending of processes and/or processing parameters and provide initial evaluation of the data – notifying Manufacturing Manager of trends.
3 Training/Personal Development/Process Improvement
Recommends scheduling or other efficiency improvements as indicated.
Conducts manufacturing activities to protect themselves, others, and company assets.
Participates in on-going training.
Completes annual GMP & safety training.
Cross trains to support other departments
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 Eisai.
Identifies process opportunities and offers suggestions.
Participates in departmental manufacturing processes and cross trains to support other departmental processes (such as area clearance).
Performs work independently
Trains others on processes and procedures.
Works with Clean Room Supervisor to schedule production and projects.
Can lead complex assignments and projects.
Demonstrates leadership and takes initiative.
4 Other duties as assigned to facilitate ongoing Eisai Baltimore/Gliadel production and/or operational activities.
4 years minimum work experience in a GMP environment required.
4 years clean room experience required.
4-year college degree in a scientific discipline or comparable experience preferred.
In depth knowledge of SOPs, batch records, GMPs which allows for review and suggestions for modification of production procedures.
OTHER DESIRED SKILLS/ABILITIES
Experience with GMP commercial product manufacturing of pharmaceutical products
Knowledge of US and EU GMP regulations
Proactive work habits.
Must be able to sit for extended periods of time.
Ability to lift/transport up to 50 pounds.
Knowledge of spray dry techniques.