PRIMARY RESPONSIBILITY: CLEAN ROOM CELL PRODUCTION

SHIFT 3:00 AM – 11:30 AM

Prepare sterile and non-sterile media and reagents for antigen production. Clean and sterilize glassware, supplies and laboratory work areas. Assist in the production of antigens to be used in the final vaccine product in a clean room environment. To ensure operations run smoothly according to the production schedule, standard operating procedures and outlines of production.

·Standard Operating Procedures (SOPs): The ability to understand and follow Marek’s Laboratory SOPs, Quality Assurance SOPs, Marek’s Laboratory Support SOPs, Universal SOP’s and other SOPs as applicable.

·Documentation: All procedures must be thoroughly documented; documentation must be legible, concurrent, and accurate.

·Clean room Laboratory Work: Requires daily gowning with sterile hooded coveralls, goggles, facemask, two pairs of gloves, and clean room boot coverings; utilization of aseptic behaviors; all procedures required for CEF production; operation of machinery and equipment used for any part of CEF preparation.

·Lab Support: Disinfection of eggs; visual inspection of eggs; stocking of all areas; deliver samples to Quality Control in a timely manner; daily temperature checks; receive shipments from the dock, ensuring items are labeled properly and are QA released before entering the production area; prepare materials for laboratory use; forklift operation; other duties as requested by leadership.

·Dishware Preparation and Sterilization: Wash, assemble, wrap and label dishware, machines, and equipment; operating autoclaves; plan according to the production schedule.

·Inventory Management: Maintain work orders that are launched by internal planners, issue items to work orders within 24 - 48 hrs of the process and complete work orders; ensure first in first out method of materials and daily checks/discarding of expired materials and samples; perform cycle counts launched by the inventory controller; ordering and restocking of lab supplies and raw materials; perform transactions in inventory software program.

·Cleaning: Prepare cleaning solutions, daily cleaning and deep cleaning of all areas the CEF department operates within; daily waste disposal, including hazardous waste.

·Shape solutions out of complexity - Work to evolve immediate environment

·Client focus - Make sure needs and requests are treated equally and in a positive way

·Collaborate with empathy - Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions taken

·Engage and develop - Open to share knowledge and to receive feedback from others

·Drive ambition and accountability - Ensure accuracy of work with the use of KPI's and a responsible commitment

·Influence others -Show structure and confidence while speaking

·Knowledge of aseptic behavior

·Attention to detail

·Ability to work outside of set schedule as needed, this may include weekends or holidays

·Mathematical aptitude

·Ensures compliance of all manufacturing processes in accordance with Regulatory Agencies (USDA, OSHA, Safety), Company Policies, Procedures, Goals, and Objectives

Education: Bachelor’s Degree in a scientific field (i.e. chemistry, general biology, cellular biology, microbial biology, etc.) or at least 1 year of experience in a related field.

Work Experience: Experienceinaregulatedbiotechor pharmaceutical industryenvironment

·Able to read, write legibly and understand English

·Stand for extended periods of time, up to six hours

·Lift up to 50 lbs

·Visual inspection

·Frequent repetitions of squatting, bending, and twisting

·Dexterity: Frequent fine motor movement

·Daily dressing and operating in clean room required garments

·Frequent repetitions of wrist and shoulder rotations

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This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

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