The Lab Technician II is a skilled, experienced member of the production team who independently supports the manufacture of synthetic RNA vaccines, from upstream production through final product filling and labeling. This role plays a key part in process execution, documentation accuracy, and continuous improvement efforts, and is responsible for mentoring junior staff and supporting transfer of the synthetic RNA platform to the site.
Responsibilities and Key Duties: |
·Independently prepare equipment and complex solutions in accordance with SOPs
·Execute upstream RNA production and downstream filling operations, including setup, operation, and troubleshooting of equipment
·Perform labeling and packaging of final product
·Launch and track work orders and inventory transactions in JDE
·Mentor and train Lab Technician I team members; serve as a knowledge resource
·Support transfer and validation activities for the synthetic RNA platform
·Identify and implement minor process improvements; escalate issues and suggest solutions
·Maintain documentation in compliance with GDP standards and support audit readiness
·Participate in investigations, deviation reporting, or change control as requested
·Cleaning of laboratories and equipment in accordance with SOPs
·Assist in the maintenance of the Synthetic Nucleotide procedures, batch records, and assist in implementation of new or improved processes as needed
·Complete additional duties as assigned
·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 receive feedback from others
·Drive ambition and accountability – Ensure accuracy of work with the use of KPI’s and responsible commitment
·Influence others – Show structure and confidence while speaking and guiding others
Technical / Functional Competencies: |
·Proficient in operating and performing equipment changeovers; able to adjust parameters to optimize performance across various types of machinery
·Demonstrates working knowledge of production procedures for qualified equipment and refers to documentation as needed
·Follows detailed instructions and adheres to production schedules
·Understands and complies with all applicable regulations, including health, safety, quality, and environmental standards
·Familiar with Lean Manufacturing principles and their purpose
·Utilizes performance management tools such as KPI tracking; applies basic problem-solving techniques to improve operations
·Applies critical thinking to resolve technical or procedural challenges
·Aware of change management concepts and capable of providing basic coaching to peers
·Applies Lean tools, including 5S, standard work, and SMED, to enhance efficiency and consistency
·Considers production standards related to time, raw material usage, productivity, and output volume
·Actively contributes to projects by providing technical expertise and delivering assigned outputs
·Knowledgeable in aseptic technique and cleanroom procedures
·Proficient in Microsoft Office tools (e.g., Excel, Word, Outlook) for documentation and communication
·Adheres to all relevant departmental policies, procedures, SOPs, and quality requirements throughout project execution
Education –
·High school diploma or GED required
·Bachelor's degree in a biological science field (i.e. microbiology, virology, biochemistry, molecular biology, or immunology) preferred
Work Experience –
·Minimum of two years of experience in cGMP laboratory experience preferred
·Experience working in an aseptic production environment required
·Experience in FDA- or EU- regulated GMP environment preferred
Other (consider certifications, specialized knowledge and/or training, etc.) – A working knowledge of microbiology, molecular biology and/or biochemistry; additional experience in related areas of biologics production, quality control, quality assurance and/or research preferred
·Ability to read, write, and communicate effectively in English
·Prolonged periods of standing, as well as occasional bending, stooping, pushing, pulling, reaching above shoulders, and stretching
·Ability to lift and carry up to 25 pounds frequently, and up to 50 pounds occasionally
·Hand-eye coordination and manual dexterity sufficient to operate laboratory equipment, including manual valves, micro-pipettes and other tools
·Ability to perform visual inspections with or without corrective lenses
·Daily use of personal protective equipment (PPE) and adherence to cleanroom garment requirements
·Frequent repetitions of bending, twisting, lifting arms above head, wrist and shoulder movements
·Clean room manufacturing laboratory in dedicated and sterile gowning and PPE
·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.
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