GID Technician

Location: Verona, WI Job Summary and Purpose (Development Process Transfer) Assist in the industrial development, process, and product improvement of viral, bacterial, parasitic and/or recombinant vaccines of licensed and unlicensed vaccines. Within the assigned internal site, he/she oversees the manufacturing and/or analytical testing of development and first commercial batches with a yearly vision. Responsibilities and Key Duties: Development & Process Transfer Sub-Family · Industrialization Strategy Definition and Management: Executes the manufacturing & testing according to the industrial development and process transfer rational (including technical, financial, and regulatory aspects) to anticipate industrial Assist in the development of state-of-the-art, robust, and cost-effective biological production processes from laboratory to industrial scale including roller bottles, multi-plate cell culture systems, bioreactors, inactivation and downstream processing for new and existing products. · Batch Manufacturing Preparation: Orders, receives & identifies the materials and components. Manages inventory - Tests technical feasibility at lab scale. Participates in industrialization process meetings. · Risk Assessments: Provides inputs in risk analysis phase (Manufacturing, EHS) and participates in risk assessment meetings. · Process Improvement: Participate in executing GID projects as assigned. Assist in optimizing existing processes. Conduct Carries out the dedicated laboratory activities in process improvement according to the relevant rules. Write process related study protocols, reports, SOP’s and manufacturing directions. Prepare summaries of test results for use in GID monthly summaries and/or reports. · Batch Manufacturing: Ensures correct batch manufacturing execution and adjust process parameters if needed during batch manufacturing; writes batch manufacturing report. Ensures correct sampling plan implementation. Submits samples to the QC labs and summarizes analytical results and writes draft validation reports. Support QC assay transfer as well as optimization & trouble shoot activities. Carries out the dedicated laboratory activities in technology transfer processes. · Training & Tech Transfer: Participate and assist in the transfer of processes into Industrial Operations. Participates in designing/leading training sessions for production operators to explain product manufacturing process and critical requirements. Participates in writing technical transfer draft report. · Production & RD Support: laboratory work as assigned on viral, bacterial, parasitic and/or recombinant vaccine projects. · Lab Management: Ensures labs preventive maintenance & qualification and updates user guides / protocols for GID. Ability to understand and use basic equipment autonomously and all complex equipment under supervision. Ensures that relevant quality standards and regulations are followed during activities. Defines/completes studies and manages daily work according to priorities (including laboratory experiments, inventory management, data management, documentation / reporting). · Internal audit & Inspection: Updates and writes instructions and forms according to relevant quality standards. Provides inputs to answer internal/external audit & inspections queries. Participates in the trials plans proposal and execution to be performed for change control activities. Provides inputs for concerned change control processes led by QA. Suggest the improvement of industrial lab practices. Core Competencies Non-exempt employees without managerial responsibilities. Perform / deliver activities in their perimeter aligned with the required process management and the right level of quality and compliance (Ceva group and local). Committed to deliver tasks and activities with a collaborative way of working within their team. ● Entrepreneur: Drive ambition and accountability – shows concern for reaching targets ● Entrepreneur: Influences others and communicates clearly ● Work Together: Collaborate with empathy – Responds to cooperation requests ● Work Together: Engage and develop – Values learning for oneself and others ● Work Smarter: Shape solutions out of complexity – Accepts needs for flexibility ● Work Smarter: Client focus – Responds appropriately for needs and requests Technical / Functional Competencies: · Development Process Transfer: Fundamental knowledge in the following areas: Bio/Pharma process, quality, EHS, regulatory, packaging, project management, data management & analysis tools. Intermediate knowledge of equipment. · General Microbiology: Virology and Bacteriology - Titration, purification, inactivation. · Tissue culture: cell lines and chicken embryo fibroblast. · 9 CFR, USA Vet. Memorandum 800s, SAM, CVB Notices. · Laboratory study design, data analysis & statistics. · Bio-safety in Microbiological and Biomedical Laboratories (BMBL). · Technical writing (USDA report, protocol and research reports). · Microsoft Office Suite. · Ability to interact within the group and cross-functional and collaborative teams. · Solid knowledge of GMP procedures. · Good communication skills both verbal and written. Qualifications: Education – Need a minimum of BA/BS in Microbiology or Biology or Chemistry/Pharmacology or related areas of expertise. Work Experience –Minimum 2 years' work experience in aseptic processing, fermentation, cell culture, and assays in research and/or manufacturing environment is preferred. Other- Basic knowledge in Microbiology and Chemistry, tissue culture, and virus titration or prior virology experience a plus. Physical Requirements: · Ability to read, write legibly and communicate in English · Visual inspection · Bending · Lifting to 50 pounds · Standing for extended periods of time Working Conditions: · Clean room manufacturing laboratory Travel Required: · Up to 5% 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 #joinceva-us