Lead Lab Technicians assist and oversee the manufacture of Live & Inactivated Chicken Embryo Origin (CEO) antigens in a controlled environment. Inactivated & Live CEO production includes working directly with a range of technologies and equipment including centrifugation, autoclaves, incubators, candling eggs, assisting with the operations of manual and semi-automatic equipment for the use of inoculation and harvesting of viruses (fluid and embryonic). As a Lead Lab Technician, you must have and demonstrate the required knowledge to operate pressurized vessels. The Lead Lab Technician will work directly with viral seed cultures and virus propagation techniques, prepare buffer/media solutions and equipment preparations, and following aseptic technique and cGMP procedures. This role is also responsible for assisting and training junior peers and entry level technicians on the lab manufacturing procedures.
| Responsibilities and Key Duties: |
·Mastery of manufacturing procedures and the ability to train team members on the lab manufacturing practices and procedures
·Assess and suggest team’s work assignments in Tier 1 meetings based on the given production schedule
·Execute production planning and reporting quality standards
·Inform and escalate issues or deviations to appropriate parties
·Control and close work orders
·Perform environmental monitoring during aseptic procedures and perform in process controls
·Use aseptic technique during processes
·Proper inoculation/harvest techniques to prevent minimal loss, process maximum yields and eliminate contamination
·Work with chemicals, steam, and pressurized vessels
·Operate general production equipment such as autoclaves, pumps, scales, bio-welders/sealers, etc. per applicable standards
·Prepare documentation for solutions and complete and check batch reports
·Monitor/assist the performance of daily cleaning and sanitation laboratories and equipment
·Assist in the implementation of safety and quality initiatives
·Ability to develop and instruct standard operating procedures (SOPs) and production records, applying all applicable standards
·Document and maintain activity records according to cGMP regulations
·Help maintain and develop effective working relationships with the team and other departments
·Utilize acceptable PPE and follow safety procedures
·Real time Cycle counts and JDE operations
·Assist in checking documentation & assist in investigations as needed
·Perform all other duties assigned
·KPI’s data collection
·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
| Technical / Functional Competencies: |
·Excellent interpersonal and organization skills
·Ability to train personnel to use equipment safely and properly
·Understand critical parameters of CEO production processes, procedures and equipment utilized
·Follow, understand, and make suggestions to the production schedule
·Can use main IT tools to perform job functions in production and apply basic computer skills
·Flexibility with schedule changes
·Strong planning and time-management skills
·Update production records and SOPs as needed
·Demonstrate and apply knowledge of lean practice methodologies and tools
·Utilize performance management tools to manage, track, and analyze KPIs
·Awareness of change management and application of basic coaching methods
·Implement action plans in alignment with KPIs and budget
·Foster a teamwork environment
·Demonstrate basic mechanical aptitude and problem-solving skills
·Education
oBachelor’s degree in a related field, preferred
·Work Experience
oInactivated & Live CEO Technician II preferred, or 2 or more years of experience with Inactivated & Live CEO processes
·Able to read, write legibly, and communicate in English
·Frequent repetitions of squatting, bending, and twisting
·Dexterity: Frequent fine motor movement
·Lift up to 25 pounds frequently and up to 50 pounds on occasions
·Standing: approximately 85% of the day
·Visual inspection
·Daily dressing and operating in clean room required garments
·Frequent repetitions of wrist and shoulder rotations
The work setting is a clean room manufacturing laboratory.
Operation of pressurized vessels
N/A
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.
669B
