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Job Summary and Purpose:

The Lab Technician I, Live Frozen is responsible for manufacturing live viral products through batching, aseptic filling, freezing, labeling, and production support activities. This position operates filling equipment, prepares production batches, maintains raw materials and inventories, performs equipment preparation and sterilization, supports final product processing, and completes production documentation while ensuring compliance with cGMP requirements, SOPs, safety standards, and production schedules.

The Lab Technician serves as a cross-functional manufacturing technician supporting all Live Frozen production operations, ensuring products are manufactured safely, efficiently, and in compliance with regulatory requirements.

Responsibilities and Key Duties:

Manufacturing Operations

        Prepare production batches following approved batch records, SOPs, and cGMP requirements.

        Operate manual and semi-automated filling equipment for aseptic filling of live viral products.

        Set up, operate, monitor, and perform changeovers on filling equipment.

        Verify batch calculations, component additions, and production parameters.

        Monitor fill weights, volumes, and process performance throughout manufacturing.

        Assist with troubleshooting minor equipment and process issues.

        Transfer intermediate and finished products between manufacturing operations.

        Maintain communication with production teams to support manufacturing schedules.

Documentation and Inventory Control

        Follow all documentation standards, including clear, accurate, and concurrent documentation practices.

        Complete, verify, organize, and submit production records, batch records, logs, and associated paperwork.

        Print and distribute current production records as needed.

        Perform cycle counts and inventory reconciliation.

        Record receipts, transfers, and inventory transactions within JDE.

        Maintain Kanban inventory systems and First-In First-Out (FIFO) inventory practices.

        Order raw materials and production supplies through vendor-managed inventory systems.

        Ensure QA-released materials are available prior to entering production areas.

Equipment Preparation and Sterilization

        Set up, clean, assemble, disassemble, and prepare manufacturing equipment for production.

        Clean laboratory dishware and production equipment.

        Wrap equipment and laboratory supplies for sterilization.

        Operate autoclaves for sterilization of laboratory equipment and supplies.

        Load and unload autoclaves while completing required documentation.

        Troubleshoot minor autoclave issues when necessary.

        Maintain organized workstations during preparation and sterilization activities.

Final Product Processing

        Monitor liquid nitrogen storage tanks, portable dewars, and associated equipment.

        Record nitrogen temperatures and liquid levels.

        Perform visual inspection of final product ampoules.

        Prepare ampoules for freezing and maintain associated inventory records.

        Operate programmable control rate freezers according to approved procedures.

        Prepare labels according to production schedules.

        Operate labeling equipment for approved final product ampoules.

        Operate dry heat ovens used for sterilization of finished ampoules.

        Complete all production records associated with freezing and labeling operations.

        Maintain line clearance procedures by processing one serial at a time.

Cleaning and Facility Maintenance

        Clean and disinfect manufacturing equipment, production rooms, support areas, kitchens, coolers, freezers, and workstations according to established procedures.

        Prepare cleaning and disinfectant solutions while maintaining associated logs.

        Remove waste, biohazard materials, dirty laboratory garments, and hazardous waste according to approved procedures.

        Complete temperature monitoring logs for manufacturing support areas.

        Maintain safe, clean, and organized work environments before, during, and after manufacturing activities.

General Responsibilities

        Utilize appropriate PPE and comply with all company safety requirements.

        Maintain effective communication and working relationships across departments.

        Support changing production priorities and schedules.

        Assist other manufacturing areas as business needs require.

        Support Lean Manufacturing and continuous improvement initiatives.

        Perform additional duties as assigned.

Core Competencies:

        Solutions out of Complexity - Continuously seeks opportunities to improve manufacturing processes and operational efficiency.

        Client Focus - Demonstrates commitment to meeting production and customer requirements.

        Collaborate with Empathy - Works effectively across departments while promoting teamwork.

        Engage and Develop - Shares knowledge and supports continuous learning.

        Drive Ambition, Accountability, and Safety - Demonstrates ownership, accuracy, and commitment to safety and quality.

        Influence Others - Communicates clearly and professionally while supporting team objectives.

Technical / Functional Competencies:

        Understanding of aseptic manufacturing techniques and cleanroom behavior.

        Ability to operate filling machines, freezers, autoclaves, and production support equipment.

        Knowledge of cGMP manufacturing requirements and Good Documentation Practices.

        Understanding of OSHA, USDA, and company safety requirements.

        Strong organizational and time-management skills.

        Excellent written and verbal communication skills.

        Ability to prioritize multiple tasks in a fast-paced manufacturing environment.

        Mechanical aptitude with the ability to troubleshoot minor equipment issues.

        Ability to work independently and as part of a cross-functional manufacturing team.

        Ability to become gown qualified.

        Flexibility to work outside normal schedules, including weekends and holidays, as business needs require.

Qualifications:

Education - Associate/Bachelor's degree in Life Science preferred but not required

Work Experience - Experience in a cGMP environment is preferred

Other (consider certifications, specialized knowledge and/or training, etc.) -

        Knowledge of cGMP and CGLP procedures is desirable

        Experience with Lean Manufacturing is preferred

Physical Requirements:

        Ability to read, write legibly and understand English

        Color vision, frequent fine motor movements of the hands and wrist, periods of short term balancing, bending, stooping, squatting, twisting and reaching below knees to above shoulders

        Ability to stand and walk >90% of work day

        Ability to push/pull 50 lbs, up to 120 lbs occasionally

        Ability to lift up to 35 lbs overhead, up to 50 lbs overhead occasionally

        Ability to carry up to 50 lbs

        Ability to get up from seated on the floor to standing without assistance 

        Ability to dress and operate in clean room environments

Working Conditions:

        Cleanroom manufacturing laboratories and production support areas.

        Exposure to varying temperatures, liquid nitrogen, biological materials, manufacturing equipment, and cleaning chemicals while following established safety procedures.

Travel Required:

        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

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