GID Technician

CEVA SANTE ANIMALE; Lenexa (KS); On-site; USD 85,000 - 115,000; Full time

Job summary

Ceva Animal Health in Lenexa, KS is seeking a candidate to assist in industrial development, process transfer, and improvement of viral, bacterial, parasitic, and recombinant vaccines. You will oversee manufacturing and analytical testing of development and first commercial batches within the assigned site.

The role requires 2+ years in aseptic processing, fermentation, cell culture, and assays; knowledge of GMP; strong communication and teamwork; and willingness to work in a clean room

Qualifications

• 2+ years of work experience in aseptic processing, fermentation, cell culture, and assays.
• Strong knowledge of GMP and regulatory requirements.
• Excellent written and verbal English communication.

Responsibilities

• Define and execute industrialization strategy for vaccine processes.
• Oversee batch manufacturing and sampling plans.
• Prepare technical transfer documents and SOPs.
• Support QA and regulatory inspections.

Skills

English communication

Teamwork

Analytical thinking

Attention to detail

Education

BA/BS in Microbiology/Biology/Chemistry/Pharmacology

Tools

Microsoft Office Suite

Job description

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your Missions

Location: Lenexa, KS

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 cult ure 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 / 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.
• All other duties as assigned

Core Competencies

• 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 –BA/BSin Microbiology, Biology or Chemistry/Pharmacology or related fields required.

Work Experience – 2+ years of work experience in aseptic processing, fermentation, cell culture, and assays in research and/or manufacturing environment is strongly 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%

• 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

Your Profile

Work Experience – 2+ years of work experience in aseptic processing, fermentation, cell culture, and assays in research and/or manufacturing environment is strongly preferred.

Other- Basic knowledge in Microbiology and Chemistry, tissue culture, and virus titration or prior virology experience a plus.